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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01431287
Registration number
NCT01431287
Ethics application status
Date submitted
8/09/2011
Date registered
9/09/2011
Date last updated
16/07/2015
Titles & IDs
Public title
Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
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Scientific title
A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2]
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Secondary ID [1]
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2009-010669-22
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Secondary ID [2]
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1237.6
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - tiotropium + olodaterol
Treatment: Drugs - tiotropium + olodaterol
Treatment: Drugs - tiotropium
Treatment: Drugs - tiotropium
Treatment: Drugs - olodaterol
Treatment: Devices - Respimat
Experimental: tiotropium+olodaterol high dose FDC - Once daily 2 puffs solution for inhalation Respimat
Experimental: tiotropium+olodaterol low dose FDC - Once daily 2 puffs solution for inhalation Respimat
Active Comparator: olodaterol - Once daily 2 puffs solution for inhalation Respimat
Active Comparator: tiotropium low dose - Once daily 2 puffs solution for inhalation Respimat
Active Comparator: tiotropium high dose - Once daily 2 puffs solution for inhalation Respimat
Treatment: Drugs: tiotropium + olodaterol
fixed dose combination
Treatment: Drugs: tiotropium + olodaterol
fixed dose combination
Treatment: Drugs: tiotropium
low dose or high dose
Treatment: Drugs: tiotropium
low dose or high dose
Treatment: Drugs: olodaterol
one dose only
Treatment: Devices: Respimat
Respimat inhaler
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169
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Assessment method [1]
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FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the MMRM model in each treatment group.
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Timepoint [1]
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1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169
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Primary outcome [2]
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Trough FEV1 Response on Day 170
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Assessment method [2]
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Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FEV1 measurements performed at 23 h and at 23 h 50 min after inhalation of study medication at the clinic visit on the previous day.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [2]
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1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170
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Primary outcome [3]
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Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).
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Assessment method [3]
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The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
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Timepoint [3]
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Day 169
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Secondary outcome [1]
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Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)
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Assessment method [1]
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Mahler Transitional Dyspnoea Index (TDI) focal score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274) is the key secondary endpoint.
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
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Timepoint [1]
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Day 169
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Secondary outcome [2]
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FEV1 AUC(0-3h) Response on Day 1
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Assessment method [2]
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FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [2]
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1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment
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Secondary outcome [3]
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FEV1 AUC(0-3h) Response on Day 85
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Assessment method [3]
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FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [3]
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1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85
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Secondary outcome [4]
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FEV1 AUC(0-3h) Response on Day 365
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Assessment method [4]
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FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [4]
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1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365
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Secondary outcome [5]
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Trough FEV1 Response on Day 15
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Assessment method [5]
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Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [5]
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1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15
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Secondary outcome [6]
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Trough FEV1 Response on Day 43
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Assessment method [6]
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Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [6]
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1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43
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Secondary outcome [7]
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Trough FEV1 Response on Day 85
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Assessment method [7]
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Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [7]
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1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1hr and 10 min pre-dose on day 85
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Secondary outcome [8]
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Trough FEV1 Response on Day 169
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Assessment method [8]
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Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [8]
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1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1hr and 10 min pre-dose on day 169
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Secondary outcome [9]
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Trough FEV1 Response on Day 365
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Assessment method [9]
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Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [9]
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1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365
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Secondary outcome [10]
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Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 1
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Assessment method [10]
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FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [10]
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1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment
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Secondary outcome [11]
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Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 85
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Assessment method [11]
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FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [11]
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1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85
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Secondary outcome [12]
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0
Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 169
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Assessment method [12]
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FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [12]
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0
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169
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Secondary outcome [13]
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0
Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 365
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Assessment method [13]
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0
FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
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Timepoint [13]
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0
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365
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Secondary outcome [14]
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Trough FVC Response on Day 15
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Assessment method [14]
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Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
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Timepoint [14]
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0
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15
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Secondary outcome [15]
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Trough FVC Response on Day 43
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Assessment method [15]
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0
Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
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Timepoint [15]
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0
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43
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Secondary outcome [16]
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Trough FVC Response on Day 85
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Assessment method [16]
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0
Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
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Timepoint [16]
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0
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85
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Secondary outcome [17]
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0
Trough FVC Response on Day 170
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Assessment method [17]
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0
Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FVC measurements performed at 23h and at 23h 50 min after inhalation of study medication at the clinic visit on the previous day.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
Query!
Timepoint [17]
0
0
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23h and at 23h 50 min after inhalation of study medication on day 170
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Secondary outcome [18]
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0
Trough FVC Response on Day 365
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Assessment method [18]
0
0
Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Query!
Timepoint [18]
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0
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 365
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Secondary outcome [19]
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0
FEV1 AUC(0-12h) Response in Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)
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Assessment method [19]
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0
FEV1 AUC(0-12h) was calculated as the area under the FEV1- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
FEV1 AUC(0-12h) response was defined as FEV1 AUC(0-12h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.
Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group.
Query!
Timepoint [19]
0
0
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169
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Secondary outcome [20]
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0
FEV1 AUC(0-24h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)
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Assessment method [20]
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0
FEV1 AUC(0-24h) was calculated as the area under the FEV1- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. FEV1 AUC(0-24h) response was defined as FEV1 AUC(0-24h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.
Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group.
Query!
Timepoint [20]
0
0
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169
Query!
Secondary outcome [21]
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0
FVC AUC(0-12h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)
Query!
Assessment method [21]
0
0
FVC AUC(0-12h) was calculated as the area under the FVC- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
FVC AUC(0-12h) response was defined as FVC AUC(0-12h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group.
Query!
Timepoint [21]
0
0
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169
Query!
Secondary outcome [22]
0
0
FVC AUC(0-24h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)
Query!
Assessment method [22]
0
0
FVC AUC(0-24h) was calculated as the area under the FVC- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.
FVC AUC(0-24h) response was defined as FVC AUC(0-24h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.
Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group.
Query!
Timepoint [22]
0
0
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169
Query!
Secondary outcome [23]
0
0
Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)
Query!
Assessment method [23]
0
0
The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
Query!
Timepoint [23]
0
0
Day 85
Query!
Secondary outcome [24]
0
0
Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)
Query!
Assessment method [24]
0
0
The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
Query!
Timepoint [24]
0
0
Day 365
Query!
Secondary outcome [25]
0
0
Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)
Query!
Assessment method [25]
0
0
Mahler TDI focal score on Day 43 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
Query!
Timepoint [25]
0
0
Day 43
Query!
Secondary outcome [26]
0
0
Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)
Query!
Assessment method [26]
0
0
Mahler TDI focal score on Day 85 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
Query!
Timepoint [26]
0
0
Day 85
Query!
Secondary outcome [27]
0
0
Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)
Query!
Assessment method [27]
0
0
Mahler TDI focal score on Day 365 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
Query!
Timepoint [27]
0
0
Day 365
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
1. Diagnosis of chronic obstructive pulmonary disease.
2. Relatively stable airway obstruction with post FEV1< 80% predicted normal and post
FEV1/FVC <70%.
3. Male or female patients, 40 years of age or older.
4. Smoking history of more than 10 pack years.
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria:
1. Significant disease other than COPD
2. Clinically relevant abnormal lab values.
3. History of asthma.
4. Diagnosis of thyrotoxicosis
5. Diagnosis of paroxysmal tachycardia
6. History of myocardial infarction within 1 year of screening visit
7. Unstable or life-threatening cardiac arrhythmia.
8. Hospitalization for heart failure within the past year.
9. Known active tuberculosis.
10. Malignancy for which patient has undergone resection, radiation therapy or
chemotherapy within last five years
11. History of life-threatening pulmonary obstruction.
12. History of cystic fibrosis.
13. Clinically evident bronchiectasis.
14. History of significant alcohol or drug abuse.
15. Thoracotomy with pulmonary resection
16. Oral ß-adrenergics.
17. Oral corticosteroid medication at unstable doses
18. Regular use of daytime oxygen therapy for more than one hour per day
19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
20. Investigational drug within one month or six half lives (whichever is greater) prior
to screening visit
21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
22. Pregnant or nursing women.
23. Women of childbearing potential not using a highly effective method of birth control
24. Patients who are unable to comply with pulmonary medication restrictions
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2013
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2539
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Idaho
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Louisiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Minnesota
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nevada
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Jersey
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Mexico
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
North Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Ohio
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Oklahoma
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Pennsylvania
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Rhode Island
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
South Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Texas
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Virginia
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Washington
Query!
Country [25]
0
0
Austria
Query!
State/province [25]
0
0
Feldbach
Query!
Country [26]
0
0
Austria
Query!
State/province [26]
0
0
Gänserndorf
Query!
Country [27]
0
0
Austria
Query!
State/province [27]
0
0
Innsbruck
Query!
Country [28]
0
0
Austria
Query!
State/province [28]
0
0
Leoben
Query!
Country [29]
0
0
Austria
Query!
State/province [29]
0
0
Linz
Query!
Country [30]
0
0
Austria
Query!
State/province [30]
0
0
Salzburg
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Brussel
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Bruxelles
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Gent
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Jambes
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Lebbeke
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Leuven
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Liège
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Oostende
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Turnhout
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
Botucatu
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Florianopolis
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Passo Fundo
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Porto Alegre
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Sao Paulo
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Alberta
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
British Columbia
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
New Brunswick
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Ontario
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Quebec
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Baotou
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Beijing
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Changsha
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Chengdu
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Chongqing
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Haikou
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Hangzhou
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Hohhot
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Jinan
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Nanjing
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Shanghai
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Shenyang
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Suzhou
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Xi'An
Query!
Country [64]
0
0
Colombia
Query!
State/province [64]
0
0
Bogota DC
Query!
Country [65]
0
0
Colombia
Query!
State/province [65]
0
0
Bogota
Query!
Country [66]
0
0
Colombia
Query!
State/province [66]
0
0
Cali
Query!
Country [67]
0
0
Colombia
Query!
State/province [67]
0
0
Floridablanca
Query!
Country [68]
0
0
Croatia
Query!
State/province [68]
0
0
Petrinja
Query!
Country [69]
0
0
Croatia
Query!
State/province [69]
0
0
Rijeka
Query!
Country [70]
0
0
Croatia
Query!
State/province [70]
0
0
Zadar
Query!
Country [71]
0
0
Croatia
Query!
State/province [71]
0
0
Zagreb
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Aschaffenburg
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Berlin
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Frankfurt
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Großhansdorf
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Halle
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Hamburg
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Hannover
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Leipzig
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Mainz
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Rodgau/Dudenhofen
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Schwerin
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Teuchern
Query!
Country [84]
0
0
Hungary
Query!
State/province [84]
0
0
Debrecen
Query!
Country [85]
0
0
Hungary
Query!
State/province [85]
0
0
Gödöllö
Query!
Country [86]
0
0
Hungary
Query!
State/province [86]
0
0
Pecs
Query!
Country [87]
0
0
Hungary
Query!
State/province [87]
0
0
Sopron
Query!
Country [88]
0
0
Hungary
Query!
State/province [88]
0
0
Szeged
Query!
Country [89]
0
0
India
Query!
State/province [89]
0
0
Chennai
Query!
Country [90]
0
0
India
Query!
State/province [90]
0
0
Coimbatore
Query!
Country [91]
0
0
India
Query!
State/province [91]
0
0
Jaipur
Query!
Country [92]
0
0
India
Query!
State/province [92]
0
0
Kolkatta
Query!
Country [93]
0
0
India
Query!
State/province [93]
0
0
Maharastra
Query!
Country [94]
0
0
India
Query!
State/province [94]
0
0
Mumbai
Query!
Country [95]
0
0
India
Query!
State/province [95]
0
0
Nashik, Maharashtra
Query!
Country [96]
0
0
India
Query!
State/province [96]
0
0
Pune
Query!
Country [97]
0
0
Ireland
Query!
State/province [97]
0
0
County Limerick
Query!
Country [98]
0
0
Ireland
Query!
State/province [98]
0
0
Dublin 24
Query!
Country [99]
0
0
Ireland
Query!
State/province [99]
0
0
Dublin 4
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Abeno-ku, Osaka, Osaka
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Aoi-ku, Shizuoka, Shizuoka
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Chuo-ku, Kobe, Hyogo
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Fukui, Fukui
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Fukuyama, Hiroshima
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Hachioji, Tokyo
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Himeji, Hyogo
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Hitachi, Ibaraki
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Iizuka, Fukuoka
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Iwamizawa, Hokkaido
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Kamakura, Kanagawa
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Kanazawa, Ishikawa
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Kanazawa, Yokohama, Kanagawa
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Kashiwa, Chiba
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Kawasaki-ku, Kawasaki, Kanagawa
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Kita-ku, Okayama, Okayama
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Kita-ku, Sakai, Osaka
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Kita-ku, Sapporo, Hokkaido
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Kurashiki, Okayama
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Minami-ku, Yokohama, Kanagawa
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Mitaka, Tokyo
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Mito, Ibaraki
Query!
Country [122]
0
0
Japan
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State/province [122]
0
0
Naha, Okinawa
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Country [123]
0
0
Japan
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State/province [123]
0
0
Nishi-ku, Kobe, Hyogo
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Country [124]
0
0
Japan
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State/province [124]
0
0
Obihiro, Hokkaido
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Country [125]
0
0
Japan
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State/province [125]
0
0
Okinawa, Okinawa
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Country [126]
0
0
Japan
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State/province [126]
0
0
Ota-ku, Tokyo
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Country [127]
0
0
Japan
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State/province [127]
0
0
Sakaide, Kagawa
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Country [128]
0
0
Japan
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State/province [128]
0
0
Sapporo, Hokkaido
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Country [129]
0
0
Japan
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State/province [129]
0
0
Shimajiri-gun, Okinawa
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Country [130]
0
0
Japan
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State/province [130]
0
0
Shinjuku-ku, Tokyo
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Country [131]
0
0
Japan
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State/province [131]
0
0
Soka, Saitama
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Country [132]
0
0
Japan
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State/province [132]
0
0
Takarazuka, Hyogo
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Country [133]
0
0
Japan
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State/province [133]
0
0
Takayama, Gifu
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Country [134]
0
0
Japan
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State/province [134]
0
0
Tomigusuku, Okinawa
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Country [135]
0
0
Japan
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State/province [135]
0
0
Toyonaka, Osaka
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Country [136]
0
0
Japan
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State/province [136]
0
0
Uji, Kyoto
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Country [137]
0
0
Japan
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State/province [137]
0
0
Yabu, Hyogo
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Country [138]
0
0
Japan
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State/province [138]
0
0
Yao, Osaka
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Country [139]
0
0
Japan
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State/province [139]
0
0
Yokosuka, Kanagawa
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Country [140]
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0
Norway
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State/province [140]
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0
Elverum
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Country [141]
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0
Norway
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State/province [141]
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0
Hønefoss
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Country [142]
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0
Norway
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State/province [142]
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0
Kløfta
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Country [143]
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0
Norway
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State/province [143]
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0
Lierskogen
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Country [144]
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0
Norway
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State/province [144]
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0
Oslo
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Country [145]
0
0
Norway
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State/province [145]
0
0
SKI
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Country [146]
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0
Norway
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State/province [146]
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0
Svelvik
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Country [147]
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0
Romania
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0
Arad
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Country [148]
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Romania
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State/province [148]
0
0
Bucharest
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Country [149]
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Romania
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State/province [149]
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0
Bucuresti
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Country [150]
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0
Romania
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State/province [150]
0
0
Cluj
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Country [151]
0
0
Russian Federation
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State/province [151]
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0
Moscow
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Country [152]
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Russian Federation
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State/province [152]
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0
St. Petersburg
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Country [153]
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0
Russian Federation
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State/province [153]
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0
Yaroslavl
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Country [154]
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0
Serbia
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State/province [154]
0
0
Belgrade
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Country [155]
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0
Serbia
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State/province [155]
0
0
Kragujevac
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Country [156]
0
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Serbia
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State/province [156]
0
0
Nis
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Country [157]
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0
Slovakia
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State/province [157]
0
0
Bardejov
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Country [158]
0
0
Slovakia
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State/province [158]
0
0
Bojnice
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Country [159]
0
0
Slovakia
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State/province [159]
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0
Kosice
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Country [160]
0
0
Slovakia
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State/province [160]
0
0
Nitra
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Country [161]
0
0
Slovakia
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State/province [161]
0
0
Spisska Nova Ves
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Country [162]
0
0
Slovakia
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State/province [162]
0
0
Zilina
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Country [163]
0
0
South Africa
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State/province [163]
0
0
Bellville
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Country [164]
0
0
South Africa
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State/province [164]
0
0
Cape Town
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Country [165]
0
0
South Africa
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State/province [165]
0
0
Pretoria
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Country [166]
0
0
Spain
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State/province [166]
0
0
Badalona (Barcelona)
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Country [167]
0
0
Spain
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State/province [167]
0
0
Barcelona
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Country [168]
0
0
Spain
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State/province [168]
0
0
Hospitalet de Llobregat
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Country [169]
0
0
Spain
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State/province [169]
0
0
Mérida
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Country [170]
0
0
Spain
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State/province [170]
0
0
Pozuelo de Alarcón
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Country [171]
0
0
Spain
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State/province [171]
0
0
San Juan de Alicante
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Country [172]
0
0
Spain
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State/province [172]
0
0
Vic (Barcelona)
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Country [173]
0
0
Sweden
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State/province [173]
0
0
Boden
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Country [174]
0
0
Sweden
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State/province [174]
0
0
Göteborg
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Country [175]
0
0
Sweden
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State/province [175]
0
0
Härnösand
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Country [176]
0
0
Sweden
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State/province [176]
0
0
Höllviken
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Country [177]
0
0
Sweden
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State/province [177]
0
0
Lund
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Country [178]
0
0
Sweden
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State/province [178]
0
0
Stockholm
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Country [179]
0
0
Sweden
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State/province [179]
0
0
Uddevalla
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Country [180]
0
0
Taiwan
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State/province [180]
0
0
Kaohsiung City
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Country [181]
0
0
Taiwan
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State/province [181]
0
0
Kaohsiung
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Country [182]
0
0
Taiwan
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State/province [182]
0
0
New Taipei City
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Country [183]
0
0
Taiwan
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State/province [183]
0
0
Taichung
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Country [184]
0
0
Taiwan
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State/province [184]
0
0
Tainan
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Country [185]
0
0
Taiwan
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State/province [185]
0
0
Taipei
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Country [186]
0
0
Taiwan
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State/province [186]
0
0
Taoyuan County
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Country [187]
0
0
Turkey
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State/province [187]
0
0
Ankara
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Country [188]
0
0
Turkey
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State/province [188]
0
0
Denizli
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Country [189]
0
0
Turkey
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State/province [189]
0
0
Istanbul
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Country [190]
0
0
Turkey
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State/province [190]
0
0
Izmir
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Country [191]
0
0
United Kingdom
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State/province [191]
0
0
Blackpool
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Country [192]
0
0
United Kingdom
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State/province [192]
0
0
Bristol
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Country [193]
0
0
United Kingdom
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State/province [193]
0
0
Chertsey
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Country [194]
0
0
United Kingdom
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State/province [194]
0
0
Fleetwood
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Country [195]
0
0
United Kingdom
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State/province [195]
0
0
Manchester
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Country [196]
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0
United Kingdom
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State/province [196]
0
0
Midsomer Norton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The overall objective of this study is to assess the efficacy and safety of 52 weeks once
daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT
Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the
RESPIMAT Inhaler) in patients with COPD.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01431287
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
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Address
0
0
Boehringer Ingelheim
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for public queries
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0
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01431287
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