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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/NCT01329029
Registration number
NCT01329029
Ethics application status
Date submitted
30/03/2011
Date registered
5/04/2011
Date last updated
13/12/2016
Titles & IDs
Public title
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting ß2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)
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Scientific title
Effect of Roflumilast on Exacerbation Rate in Patients With COPD Treated With Fixed Combinations of LABA and ICS. A 52-week, Randomised Double-blind Trial With Roflumilast 500 µg Versus Placebo. The REACT Trial
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Secondary ID [1]
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2010-019685-87
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Secondary ID [2]
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RO-2455-404-RD
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Universal Trial Number (UTN)
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Trial acronym
REACT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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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 - Roflumilast
Treatment: Drugs - Placebo
Active Comparator: Roflumilast - concomitant medication: fixed combination of long-acting ß2-agonist and inhaled glucocorticosteroid
Placebo Comparator: Placebo - concomitant medication: fixed combination of long-acting ß2-agonist and inhaled glucocorticosteroid
Treatment: Drugs: Roflumilast
500 µg, once daily
Treatment: Drugs: Placebo
once daily
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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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Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year
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Assessment method [1]
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A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.
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Timepoint [1]
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52 weeks
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Secondary outcome [1]
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Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1)
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Assessment method [1]
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Pulmonary function testing was performed using centralised spirometry. FEV1 is the maximum amount of air that can be forcefully exhaled in one second. Least-squares means is from Analysis of Covariance (ANCOVA) including treatment by time interaction. A positive change from Baseline indicates improvement.
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Timepoint [1]
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Baseline and Week 52
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Secondary outcome [2]
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Rate of Severe COPD Exacerbations Per Patient Per Year
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Assessment method [2]
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A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. Severe COPD exacerbations were categorized as requiring hospitalization and/or leading to death. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.
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Timepoint [2]
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52 weeks
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Secondary outcome [3]
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Rate of COPD Exacerbations Per Patient Per Year All Categories
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Assessment method [3]
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A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.
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Timepoint [3]
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52 weeks
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Secondary outcome [4]
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Percentage of Participants Experiencing at Least 1 COPD Exacerbation
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Assessment method [4]
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A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.
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Timepoint [4]
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52 weeks
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Secondary outcome [5]
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Time to First COPD Exacerbation All Categories
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Assessment method [5]
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Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for all events: mild, moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.
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Timepoint [5]
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52 Weeks
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Secondary outcome [6]
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Time to Second Moderate or Severe COPD Exacerbation
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Assessment method [6]
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Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.
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Timepoint [6]
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52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
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Secondary outcome [7]
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Time to Third Moderate or Severe COPD Exacerbation
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Assessment method [7]
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Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.
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Timepoint [7]
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52 Weeks
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Secondary outcome [8]
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Number of Patients Needed to Treat to Avoid 1 Moderate or Severe COPD Exacerbation Derived From Exacerbation Per Patient Per Year
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Assessment method [8]
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The number needed to treat (NNT) analysis is a simple, concise method to quantify directly the benefits that alternative treatment options have on disease outcomes in terms of the number of patients who need to be treated before a benefit is observed. Risk reduction: Rate(Placebo)- Rate (Roflumilast 500 µg), Number needed to treat for benefit (NNTB): 1/(Risk reduction). A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.
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Timepoint [8]
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52 Weeks
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Secondary outcome [9]
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Number of Moderate or Severe COPD Exacerbation Days
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Assessment method [9]
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A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. The number of exacerbation days per patient is the sum of durations (stop date of exacerbation - start date of exacerbation + 1) of all exacerbations within the category.
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Timepoint [9]
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52 Weeks
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Secondary outcome [10]
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Duration of Moderate or Severe COPD Exacerbations Per Participant
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Assessment method [10]
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A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.
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Timepoint [10]
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52 Weeks
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Secondary outcome [11]
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Change From Baseline in Post-Bronchodilator Forced Vital Capacity (FVC)
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Assessment method [11]
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Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement.
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Timepoint [11]
0
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52 weeks
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Secondary outcome [12]
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Change From Baseline in Post-Bronchodilator Forced Expiratory Flow at 25% to 75% of Vital Capacity (FEF25-75%)
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Assessment method [12]
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Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement.
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Timepoint [12]
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52 weeks
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Secondary outcome [13]
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Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First 6 Seconds (FEV6)
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Assessment method [13]
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FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first six seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement.
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Timepoint [13]
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52 weeks
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Secondary outcome [14]
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Change From Baseline in Post-Bronchodilator FEV1/FVC
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Assessment method [14]
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The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement.
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Timepoint [14]
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52 weeks
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Secondary outcome [15]
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Change From Baseline in Use of Rescue Medication From Daily Diary
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Assessment method [15]
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Salbutamol metered dose inhaler was available as rescue medication during the study. The participant recorded the use of rescue medication in a daily diary. A negative change from Baseline indicates an improvement.
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Timepoint [15]
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Baseline and Week 52
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Secondary outcome [16]
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Change From Baseline in COPD Symptom Score From Daily Diary
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Assessment method [16]
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Participants recorded COPD symptoms cough and sputum production in a daily diary. Cough was assessed using a 4-point scale where 0=No cough to 3=severe cough and sputum was assessed using a 4-point scale where 0=no sputum production to 3=severe sputum production. Least-squares means from ANCOVA including treatment by time interaction. A negative change from Baseline indicates improvement. Total symptom score is the sum of cough and sputum scores, ranging from 0 (best possible outcome) to 6 (worst possible outcome).
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Timepoint [16]
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52 weeks
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Secondary outcome [17]
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Percentage of Symptom-Free Days
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Assessment method [17]
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Symptoms of COPD (cough, sputum) were recorded in a daily diary. The percentage of days without symptoms is reported.
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Timepoint [17]
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52 Weeks
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Secondary outcome [18]
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Percentage of Rescue Medication-Free Days
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Assessment method [18]
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Participants recorded their use of rescue medication in a daily diary. The percentage of days without rescue medication use.
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Timepoint [18]
0
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52 Weeks
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Secondary outcome [19]
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Change From Baseline in COPD Assessment Test (CAT) Total Score
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Assessment method [19]
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Participants completed the CAT questionnaire at Baseline and after 52 Weeks of Treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. A negative change from Baseline indicates improvement. Least-squares means from ANCOVA including treatment by time interaction.
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Timepoint [19]
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Baseline and Week 52
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Secondary outcome [20]
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Percentage of Participants With Improvement in CAT
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Assessment method [20]
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Participants completed the CAT questionnaire at Baseline and after 52 Weeks of treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. Improvement was defined as a CAT Total Score reduction from Baseline > 1.6.
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Timepoint [20]
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Baseline and Week 52
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Secondary outcome [21]
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Time to Mortality Due to Any Reason During the Treatment Period Score
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Assessment method [21]
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Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
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Timepoint [21]
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52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
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Secondary outcome [22]
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Time to Mortality Due to COPD Exacerbation During the Treatment Period
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Assessment method [22]
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Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
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Timepoint [22]
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52 Weeks
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Secondary outcome [23]
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Time to Withdrawal During the Treatment Period
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Assessment method [23]
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Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
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Timepoint [23]
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52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
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Secondary outcome [24]
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Time to Withdrawal Due to COPD Exacerbation During the Treatment Period
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Assessment method [24]
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Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
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Timepoint [24]
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52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
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Secondary outcome [25]
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Percentage of Participants With Major Adverse Cardiovascular Event (MACE) During the Treatment Period
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Assessment method [25]
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Composite MACE is a combined endpoint (cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke).
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Timepoint [25]
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52 Weeks
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Secondary outcome [26]
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Time to First Major Adverse Cardiovascular Event (MACE) During the Treatment Period
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Assessment method [26]
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Composite MACE is a combined endpoint(cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke). Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
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Timepoint [26]
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52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
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Secondary outcome [27]
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Percentage of Participant With All-Cause Hospitalisation During the Treatment Period
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Assessment method [27]
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Percentage of patients with at least one hospital admission due to any cause.
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Timepoint [27]
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52 Weeks
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Secondary outcome [28]
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Time to First Hospitalisation Due to Any Cause During the Treatment Period
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Assessment method [28]
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Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
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Timepoint [28]
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52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
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Secondary outcome [29]
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Time to Trial Withdrawal Due to an Adverse Event
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Assessment method [29]
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Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
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Timepoint [29]
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52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
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Secondary outcome [30]
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Percentage of Participants Who Experienced at Least 1 Treatment Emergent Adverse Event (TEAE)
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Assessment method [30]
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An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
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Timepoint [30]
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52 Weeks
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Secondary outcome [31]
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Change From Baseline in Body Weight
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Assessment method [31]
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Least Square Means was from an ANCOVA model including Last Observation Carried Forward (LOCF).
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Timepoint [31]
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Baseline and Week 52
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Secondary outcome [32]
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Change From Baseline in Body Mass Index (BMI)
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Assessment method [32]
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Body mass index (BMI) is a measure of body fat based on height and weight. Least Square Means was from an ANCOVA model including LOCF.
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Timepoint [32]
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Baseline and Week 52
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Eligibility
Key inclusion criteria
- Giving written informed consent
- History of COPD (according to GOLD 2009) for at least 12 months prior to baseline
Visit V0 associated with chronic productive cough for 3 months in each of the 2 years
prior to baseline visit (with other causes of productive cough excluded)
- Age = 40 years
- Forced expiratory volume after one second (FEV1)/forced vital capacity (FVC) ratio
(post-bronchodilator) < 70%
- FEV1 (post-bronchodilator) = 50% of predicted
- At least two documented moderate or severe COPD exacerbations within one year prior to
baseline visit
- Patients must be pre-treated with LABA and ICS for at least 12 months before baseline
Visit V0. Up to 3 months before baseline Visit V0 free or fixed combinations of LABA
and ICS are allowed, including changes in dose, active substances, and brands. In the
last 3 months before baseline Visit V0 patients must be pre-treated with fixed
combinations of LABA and ICS at a constant dose (maximum approved dosage strength of
the combination).
- Former smoker (defined as smoking cessation at least one year ago) or current smoker
both with a smoking history of at least 20 pack years
Main
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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
- Exacerbations not resolved at first baseline visit
- Diagnosis of asthma and/or other relevant lung disease
- Known alpha-1-antitrypsin deficiency
- Other protocol-defined exclusion criteria may apply
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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
1/05/2011
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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
1/05/2014
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Sample size
Target
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Accrual to date
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Final
1945
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Nycomed Investigational Site - Box Hill
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Recruitment hospital [2]
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Nycomed Investigational Site - Clayton
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Recruitment hospital [3]
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Nycomed Investigational Site - Concord
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Recruitment hospital [4]
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Nycomed Investigational site - Daws Park
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Recruitment hospital [5]
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Nycomed Investigational Site - Frankston
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Recruitment hospital [6]
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Nycomed Investigational Site - Heidelberg
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Recruitment hospital [7]
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Nycomed Investigational Site - Parkville
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Recruitment hospital [8]
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Nycomed Investigational Site - Toorak Gardens
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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2139 - Concord
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Recruitment postcode(s) [4]
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5041 - Daws Park
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Recruitment postcode(s) [5]
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3199 - Frankston
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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3050 - Parkville
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Recruitment postcode(s) [8]
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5065 - Toorak Gardens
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Feldbach
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Country [2]
0
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Austria
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State/province [2]
0
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Graz
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Country [3]
0
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Austria
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State/province [3]
0
0
Salzburg
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0
0
Austria
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State/province [4]
0
0
Wien
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Country [5]
0
0
Belgium
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State/province [5]
0
0
Bruxelles
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Country [6]
0
0
Belgium
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State/province [6]
0
0
Halen
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Country [7]
0
0
Belgium
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State/province [7]
0
0
Liege
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Country [8]
0
0
Belgium
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State/province [8]
0
0
Malmedy
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Country [9]
0
0
Brazil
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State/province [9]
0
0
Belo Horizonte
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Country [10]
0
0
Brazil
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State/province [10]
0
0
Botucatu
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Country [11]
0
0
Brazil
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State/province [11]
0
0
Florianópolis
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Country [12]
0
0
Brazil
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State/province [12]
0
0
Goiânia
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Country [13]
0
0
Brazil
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State/province [13]
0
0
Porto Alegre
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Country [14]
0
0
Brazil
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State/province [14]
0
0
Rio de Janeiro
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Country [15]
0
0
Brazil
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State/province [15]
0
0
Sao Paolo
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Country [16]
0
0
Brazil
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State/province [16]
0
0
Vitória
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Country [17]
0
0
Canada
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State/province [17]
0
0
Hamilton
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Country [18]
0
0
Canada
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State/province [18]
0
0
Kingston
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Country [19]
0
0
Canada
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State/province [19]
0
0
Lachine
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Country [20]
0
0
Canada
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State/province [20]
0
0
Niagara Falls
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Country [21]
0
0
Canada
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State/province [21]
0
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Richmond Hill
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Country [22]
0
0
Canada
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State/province [22]
0
0
Toronto
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Country [23]
0
0
Canada
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State/province [23]
0
0
Winnepeg
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Country [24]
0
0
Denmark
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State/province [24]
0
0
Hellerup
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Country [25]
0
0
Denmark
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State/province [25]
0
0
Hillerød
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Country [26]
0
0
Denmark
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State/province [26]
0
0
Hvidovre
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Country [27]
0
0
Denmark
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State/province [27]
0
0
København NV
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Country [28]
0
0
France
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State/province [28]
0
0
Férolles Attilly
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Country [29]
0
0
France
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State/province [29]
0
0
Nîmes
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Country [30]
0
0
France
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State/province [30]
0
0
Poitiers
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Country [31]
0
0
France
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State/province [31]
0
0
Saint-Laurent du Var
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Country [32]
0
0
France
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State/province [32]
0
0
Strasbourg
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Country [33]
0
0
Germany
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State/province [33]
0
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Berlin
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Country [34]
0
0
Germany
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State/province [34]
0
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Fürth
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Israel
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Italy
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Italy
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Russian Federation
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St. Petersburg
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Volgograd
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Russian Federation
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Russian Federation
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Martin
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Spisska Nova Ves
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South Africa
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South Africa
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Johannesburg
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South Africa
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Morningside, Johannesburg Gauteng
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South Africa
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Mersin
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United Kingdom
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Edinburgh
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United Kingdom
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London
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United Kingdom
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Norwich
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Ethics approval
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Summary
Brief summary
The objective of the REACT trial is to investigate the effect of roflumilast 500 µg tablets
once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who
are concomitantly treated with a fixed combination of long-acting ß2-agonists (LABA) and
inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of
roflumilast will be obtained. An additional objective is to further characterize the
population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further
characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of
efficacy and relevant safety aspects.
Patients to be included are required to have severe COPD associated with chronic bronchitis
and a history of frequent exacerbations and must be concomitantly treated with a fixed
combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 µg once daily and
placebo) are included.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01329029
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Public notes
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Contacts
Principal investigator
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AstraZeneca AstraZeneca
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AstraZeneca
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01329029
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