REACTEffect 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
Roflumilast
+ Placebo
Chronic Disease+5
+ Lung Diseases
+ Lung Diseases, Obstructive
Treatment Study
Summary
Study start date: May 1, 2011
Actual date on which the first participant was enrolled.The drug tested in this study is called Roflumilast. Roflumilast is being developed to treat people who have chronic obstructive pulmonary disease (COPD). This study investigated the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate, pulmonary function, and major adverse cardiovascular events (MACE) in COPD patients who were concomitantly treated with a fixed combination of long-acting beta-agonists (LABA) and inhaled glucocorticosteroids. The study was targeted to enroll approximately 1934 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * Roflumilast 500 μg once daily * Placebo (dummy inactive pill) - this was a tablet that looked like the study drug but had no active ingredient Trial treatment was taken in the morning by mouth after breakfast with some water. The trial consisted of the following periods: * Single-blind baseline period (4 weeks) during which all patients received placebo. * Double-blind treatment period (52 weeks) during which patients received either roflumilast or matching placebo. * Safety follow-up (30 days after end of treatment (Vend) or premature discontinuation date) in case of ongoing Adverse Events at Vend, if necessary. * Follow-up visit 12 weeks after end of treatment, at Week 64 (VFU), only for patients who completed the trial as scheduled. This multi-center trial was conducted worldwide. The overall time to participate in this study was up to 64 weeks. Participants made multiple visits to the clinic which included a follow-up visit at week 64.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1945 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 180 locations
Nycomed Investigational Site
Roma, ItalyNycomed Investigational Site
Clayton, AustraliaNycomed Investigational Site
Concord, Australia