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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/NCT00975195
Registration number
NCT00975195
Ethics application status
Date submitted
10/09/2009
Date registered
11/09/2009
Date last updated
10/02/2015
Titles & IDs
Public title
Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
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Scientific title
A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy
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Secondary ID [1]
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2007-002522-29
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Secondary ID [2]
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352.2046
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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 inhalation
Treatment: Drugs - salmeterol xinafoate
Treatment: Drugs - fluticasone propionate
Treatment: Drugs - placebo matched for fluticasone propionate
Experimental: fluticasone high dose - fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate
Experimental: fluticasone medium & low doses - fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Treatment: Drugs: tiotropium inhalation
Treatment: Drugs: salmeterol xinafoate
Treatment: Drugs: fluticasone propionate
Treatment: Drugs: placebo matched for fluticasone propionate
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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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Time to First Moderate or Severe On-treatment COPD Exacerbation
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Assessment method [1]
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A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of =2 lower respiratory symptoms related to COPD, with =1 symptom lasting =3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval.
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Timepoint [1]
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During randomised treatment, up to 488 days
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Secondary outcome [1]
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Number of Moderate or Severe On-treatment COPD Exacerbations
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Assessment method [1]
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Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was =7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if =1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.
Measured values show adjusted mean event rate.
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Timepoint [1]
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During randomised treatment, up to 488 days
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Secondary outcome [2]
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Proportion of Patients With =1 Moderate or Severe On-treatment COPD Exacerbation
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Assessment method [2]
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Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.
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Timepoint [2]
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During randomised treatment, up to 488 days
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Secondary outcome [3]
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Time to First Severe On-treatment COPD Exacerbation
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Assessment method [3]
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Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.
The "measure type" displays the 25th percentile and its 95% confidence interval.
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Timepoint [3]
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During randomised treatment, up to 488 days
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Secondary outcome [4]
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Number of Severe On-treatment COPD Exacerbations
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Assessment method [4]
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Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was =7 days after the end date of the first exacerbation event were combined and counted as severe if =1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.
Measured values show adjusted event rate.
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Timepoint [4]
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During randomised treatment, up to 488 days
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Secondary outcome [5]
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Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.
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Assessment method [5]
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Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.
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Timepoint [5]
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During randomised treatment, up to 488 days
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Secondary outcome [6]
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Time to First On-treatment COPD Exacerbation
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Assessment method [6]
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Time to first on-treatment COPD exacerbation of any severity. The "measure type" displays the 25th percentile and its 95% confidence interval.
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Timepoint [6]
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During randomised treatment, up to 488 days
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Secondary outcome [7]
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Number of On-treatment COPD Exacerbations
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Assessment method [7]
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Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was =7 days after the end date of the first exacerbation event were combined.
Measured values show adjusted event rate.
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Timepoint [7]
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During randomised treatment, up to 488 days
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Secondary outcome [8]
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Proportion of Patients With at Least One On-treatment COPD Exacerbation
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Assessment method [8]
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Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.
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Timepoint [8]
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During randomised treatment, up to 488 days
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Secondary outcome [9]
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Severity of On-treatment COPD Exacerbations
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Assessment method [9]
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Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)
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Timepoint [9]
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During randomised treatment, up to 488 days
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Secondary outcome [10]
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Change in On-treatment Lung Function as Measured by Trough FEV1
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Assessment method [10]
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Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [10]
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Baseline and week 6, 12, 18 and 52 visits
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Secondary outcome [11]
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Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale
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Assessment method [11]
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Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health.
Scale from 0 to 4:
0 = not troubled by breathlessness, except during strenuous exercise
1 = short of breath when hurrying or walking up a slight hill
2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace
3 = stops for breath after approximately 100 yards, or after a few minutes on the level
4 = too breathless to leave the house, or breathless when dressing or undressing
"No breathlessness" was given a score of -1
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [11]
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Baseline and week 18 and 52 visits
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Secondary outcome [12]
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Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)
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Assessment method [12]
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Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [12]
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Baseline and week 18 and 52 visits
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Secondary outcome [13]
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Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)
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Assessment method [13]
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Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [13]
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Baseline and week 18 and 52 visits
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Secondary outcome [14]
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Change in On-treatment BODE Index
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Assessment method [14]
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Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [14]
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Baseline and week 18 and 52 visits
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Secondary outcome [15]
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Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain
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Assessment method [15]
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Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [15]
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Baseline and week 12, 18 and 52 visits
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Secondary outcome [16]
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Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain
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Assessment method [16]
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Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [16]
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Baseline and week 12, 18 and 52 visits
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Secondary outcome [17]
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Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain
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Assessment method [17]
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Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [17]
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Baseline and week 12, 18 and 52 visits
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Secondary outcome [18]
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Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain
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Assessment method [18]
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Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [18]
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Baseline and week 12, 18 and 52 visits
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Secondary outcome [19]
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Change in On-treatment FEV1 as Measured by Home Based Spirometry
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Assessment method [19]
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Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if =4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [19]
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Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
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Secondary outcome [20]
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Change in On-treatment FVC as Measured by Home Based Spirometry
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Assessment method [20]
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Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if =4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [20]
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Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
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Secondary outcome [21]
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Change in On-treatment PEFR as Measured by Home Based Spirometry
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Assessment method [21]
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Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [21]
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Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
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Secondary outcome [22]
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Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain
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Assessment method [22]
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Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [22]
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Baseline and week 27 and 52 visits
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Secondary outcome [23]
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Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain
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Assessment method [23]
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Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [23]
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Baseline and week 27 and 52 visits
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Secondary outcome [24]
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Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain
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Assessment method [24]
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Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [24]
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Baseline and week 27 and 52 visits
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Secondary outcome [25]
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Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score
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Assessment method [25]
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Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [25]
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Baseline and week 27 and 52 visits
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Secondary outcome [26]
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Change in On-treatment Physician Global Evaluation
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Assessment method [26]
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Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
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Timepoint [26]
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Baseline and week 27 and 52 visits
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Male or female aged 40 years or more
2. Severe to very severe chronic obstructive pulmonary disease (COPD)
3. Current or ex-smoker with smoking history of at least 10 pack years
4. At least one documented exacerbation of COPD in previous year
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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:
1. Significant diseases other than COPD; significant alcohol or drug abuse
2. Current clinical diagnosis of asthma requiring steroid treatment
3. History of thoracotomy with pulmonary resection
4. Regular use of daytime oxygen
5. Recent history (within 3 months) of myocardial infarction
6. Recent (within 6 weeks) respiratory infection or COPD exacerbation
7. Recent (within 6 weeks) treatment with systemic corticosteroids at doses in excess of
5milligram / day
8. Recent (within 3 months) unstable or life-threatening cardiac arrhythmia requiring
intervention
9. Recent (within 1 year) hospitalisation for cardiac failure
10. Malignancy requiring chemotherapy or radiotherapy
11. Clinical diagnosis of bronchiectasis
12. Pregnant or nursing women
13. Known hypersensitivity to study drugs
14. Current or recent (within 30 days) participation in another clinical study
15. Current participation in or recent completion (within 4 weeks) of a pulmonary
rehabilitation program
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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?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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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
1/02/2009
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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
1/07/2013
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Sample size
Target
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Accrual to date
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Final
2488
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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352.2046.61006 Boehringer Ingelheim Investigational Site - Concord
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Recruitment hospital [2]
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352.2046.61001 Boehringer Ingelheim Investigational Site - Glebe
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Recruitment hospital [3]
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352.2046.61002 Boehringer Ingelheim Investigational Site - Westmead
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Recruitment hospital [4]
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352.2046.61004 Boehringer Ingelheim Investigational Site - Daw Park
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Recruitment hospital [5]
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352.2046.61003 Boehringer Ingelheim Investigational Site - Toorak Gardens
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Recruitment hospital [6]
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352.2046.61005 Boehringer Ingelheim Investigational Site - Woodville
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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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- Glebe
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Recruitment postcode(s) [3]
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- Westmead
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Recruitment postcode(s) [4]
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- Daw Park
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Recruitment postcode(s) [5]
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- Toorak Gardens
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Recruitment postcode(s) [6]
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- Woodville
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Bruxelles
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Country [2]
0
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Belgium
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State/province [2]
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Eupen
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Country [3]
0
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Belgium
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State/province [3]
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Gilly
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Country [4]
0
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Belgium
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State/province [4]
0
0
Herentals
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Country [5]
0
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Belgium
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State/province [5]
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0
Jambes
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Country [6]
0
0
Belgium
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State/province [6]
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0
Lebbeke
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Country [7]
0
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Belgium
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State/province [7]
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Leuven
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Country [8]
0
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Belgium
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State/province [8]
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Middelheim
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Country [9]
0
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Belgium
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State/province [9]
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Montigny-le-Tilleul
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Country [10]
0
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Belgium
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State/province [10]
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0
Turnhout
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Country [11]
0
0
Brazil
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State/province [11]
0
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Goiania
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Country [12]
0
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Brazil
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State/province [12]
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Goiânia
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Country [13]
0
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Brazil
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State/province [13]
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Porto Alegre
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Country [14]
0
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Brazil
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State/province [14]
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Sao Paulo
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Country [15]
0
0
Bulgaria
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State/province [15]
0
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Bourgas
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Country [16]
0
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Bulgaria
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State/province [16]
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Rousse
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Country [17]
0
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Bulgaria
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State/province [17]
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Sofia
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Country [18]
0
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Bulgaria
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State/province [18]
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Stara Zagora
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Country [19]
0
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Bulgaria
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State/province [19]
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Veliko Tarnovo
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Country [20]
0
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China
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State/province [20]
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Beijing
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Country [21]
0
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China
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State/province [21]
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Chongqing
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Country [22]
0
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China
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State/province [22]
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Guangzhou
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Country [23]
0
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China
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State/province [23]
0
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Shanghai
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Country [24]
0
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China
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State/province [24]
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Wuhan
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Country [25]
0
0
Denmark
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State/province [25]
0
0
Aarhus C
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Country [26]
0
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Denmark
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State/province [26]
0
0
København NV
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Country [27]
0
0
Denmark
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State/province [27]
0
0
Odense C
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Country [28]
0
0
France
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State/province [28]
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0
Brest
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Country [29]
0
0
France
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State/province [29]
0
0
Castelnau le Lez
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Country [30]
0
0
France
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State/province [30]
0
0
Clermont Ferrand cedex 1
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Country [31]
0
0
France
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State/province [31]
0
0
Forbach
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Country [32]
0
0
France
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State/province [32]
0
0
Marseille cedex 20
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Country [33]
0
0
France
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State/province [33]
0
0
Marseille
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France
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Nantes
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France
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France
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Germany
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Cegled
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Hungary
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Hungary
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Hungary
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Hungary
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Catania
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Italy
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Cona
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Italy
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Italy
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Modena
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Italy
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Italy
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Pisa
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Italy
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Italy
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Tradate (va)
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Heerlen
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Hamilton
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New Zealand
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New Zealand
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Tauranga
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Quezon
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Bytom
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Poland
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Ostrow Wielkopolska
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Poland
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Poznan
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Poland
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Rzeszow
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Poland
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Russian Federation
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Russian Federation
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Russian Federation
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St. Petersburg
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Russian Federation
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South Africa
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Pretoria
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South Africa
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Badajoz
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Hospitalet de Llobregat
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Spain
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Ariana
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Tunis
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Turkey
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Denizli
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Istanbul
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Samsun
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Kharkov
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Kiev
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Ukraine
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Vinnytsya
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United Kingdom
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Baillieston, Glasgow
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United Kingdom
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Barnsley
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United Kingdom
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Belfast
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United Kingdom
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Birmingham
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United Kingdom
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Cambridge
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United Kingdom
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Chertsey
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United Kingdom
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Chesterfield
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United Kingdom
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Cottingham, Hull
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United Kingdom
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Inverness
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United Kingdom
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Isleworth
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United Kingdom
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Liverpool
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United Kingdom
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London
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Norwich
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Sheffield
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United Kingdom
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Sunderland
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United Kingdom
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Windsor
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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
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Summary
Brief summary
This is a randomised study to be conducted in patients with severe to very severe Chronic
Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients
to be continuously treated with an inhaled corticosteroid on top of two potent long-acting
bronchodilators. The study also aims to identify the type of patients who are likely to
benefit from inhaled corticosteroid maintenance therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00975195
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Public notes
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Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
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Boehringer Ingelheim
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00975195
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