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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/NCT02006732
Registration number
NCT02006732
Ethics application status
Date submitted
14/10/2013
Date registered
10/12/2013
Date last updated
20/01/2016
Titles & IDs
Public title
Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)
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Scientific title
A Randomised, Double-blind, Placebo- and Active-controlled Parallel Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium+ Olodaterol Fixed Dose Combination (Delivered by the Respimat Inhaler) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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Secondary ID [1]
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2013-002264-24
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Secondary ID [2]
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1237.26
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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 - olodaterol
Treatment: Drugs - tiotropium
Treatment: Drugs - placebo
Experimental: tiotropium + olodaterol low dose - Once daily 2 puffs solution for inhalation Respimat
Experimental: tiotropium + olodaterol high dose - Once daily 2 puffs solution for inhalation Respimat
Active Comparator: tiotropium - Once daily 2 puffs solution for inhalation Respimat
Placebo Comparator: placebo - Once daily 2 puffs solution for inhalation Respimat
Treatment: Drugs: olodaterol
fixed dose combination
Treatment: Drugs: tiotropium
fixed dose combination
Treatment: Drugs: placebo
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Intervention code [1]
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Treatment: Drugs
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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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FEV1 AUC0-3h Response
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Assessment method [1]
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Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a 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 a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
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Timepoint [1]
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baseline and 12 weeks
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Primary outcome [2]
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Trough FEV1 Response (Change From Baseline)
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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). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a 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 a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
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Timepoint [2]
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baseline and 12 weeks
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Primary outcome [3]
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St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study
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Assessment method [3]
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The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
The adjusted mean (SE) are obtained from fitting a 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 a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
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Timepoint [3]
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12 weeks treatment
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Primary outcome [4]
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St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
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Assessment method [4]
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This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
The adjusted mean (SE) are obtained from fitting a 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 a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
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Timepoint [4]
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12 weeks treatment
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Secondary outcome [1]
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Trough Forced Vital Capacity (FVC) Response (Change From Baseline)
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Assessment method [1]
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Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a 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 a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
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Timepoint [1]
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baseline and 12 weeks
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Secondary outcome [2]
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TDI Focal Score Based on Data From This Individual Study
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Assessment method [2]
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Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).
The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
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Timepoint [2]
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12 weeks
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Secondary outcome [3]
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TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
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Assessment method [3]
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This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).
The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
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Timepoint [3]
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12 weeks
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Secondary outcome [4]
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FVC AUC0-3h Response (Change From Baseline)
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Assessment method [4]
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The adjusted mean (SE) are obtained from fitting a 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 a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
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Timepoint [4]
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baseline and 12 weeks
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Diagnosis chronic obstructive pulmonary disease
- Relatively stable airway obstruction with post FEV1 >=30 and < 80% predicted normal
and post FEV1/ FVC < 70%
- Male or female patients, 40 years of age or more
- Smoking history more than 10 pack years
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- Significant diseases other than COPD
- History of asthma
- COPD exacerbation in previous 3 months
- Completion of pulmonary rehabilitation program within previous 6 weeks or current
participation in pulmonary rehabilitation program.
- Pregnant or nursing women
- Patients unable to comply with pulmonary medication restrictions
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2014
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Sample size
Target
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Accrual to date
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Final
809
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
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Recruitment hospital [1]
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1237.26.61004 Boehringer Ingelheim Investigational Site - Concord
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Recruitment hospital [2]
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1237.26.61002 Boehringer Ingelheim Investigational Site - Daw Park
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Recruitment hospital [3]
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1237.26.61003 Boehringer Ingelheim Investigational Site - Toorak Gardens
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Recruitment hospital [4]
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1237.26.61007 Boehringer Ingelheim Investigational Site - Woodville
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Recruitment hospital [5]
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1237.26.61005 Boehringer Ingelheim Investigational Site - Murdoch
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Recruitment hospital [6]
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1237.26.61001 Boehringer Ingelheim Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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- Concord
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Recruitment postcode(s) [2]
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- Daw Park
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Recruitment postcode(s) [3]
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- Toorak Gardens
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Recruitment postcode(s) [4]
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- Woodville
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Recruitment postcode(s) [5]
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- Murdoch
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Recruitment postcode(s) [6]
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- Nedlands
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Recruitment outside Australia
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United States of America
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Alabama
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Connecticut
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Florida
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Missouri
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North Carolina
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Ohio
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Oklahoma
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Texas
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West Virginia
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Austria
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Feldbach
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Austria
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Grieskirchen
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Austria
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Linz
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Austria
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Thalheim bei Wels
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New Brunswick
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Ontario
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Bamberg
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Bochum
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Frankfurt
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Hettstedt
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Leipzig
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Germany
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Lübeck
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Germany
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Rüdersdorf
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Germany
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Schwerin
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Wiesloch
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Athens
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Heraklion
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Serres
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Greece
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Thessaloniki
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New Zealand
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Greenlane East Auckland NZ
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Norway
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Hamar
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Hønefoss
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Kløfta
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Norway
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Lierskogen
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Slovakia
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Bardejov
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Slovakia
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Humenne
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Slovakia
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Spisska Nova Ves
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Slovakia
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Vysne Hagy
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South Africa
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Cape Town
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South Africa
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Durban
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Sweden
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Höllviken
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Uddevalla
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this study is to assess the efficacy and safety of 12 weeks once daily
treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler)
compared with tiotropium and placebo in patients with COPD.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02006732
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Boehringer Ingelheim
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Address
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Boehringer Ingelheim
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02006732
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