Chronic Obstructive Pulmonary Disease Clinical Trial
Official 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
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 β2-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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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