Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)

Sponsor
AstraZeneca
Study ID
NCT01329029
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    500 µg, once daily
  • Placebo — DRUG
    once daily

Study Details

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.

Key Dates

Start date
May 31, 2011
Status verified
Sep 2016
Primary completion
Mar 31, 2014
Completion
May 31, 2014

Study Design

Enrollment
1,945 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Roflumilast
    concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid
  • Placebo Comparator: Placebo
    concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid

Primary Outcome Measure

Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year [ Time Frame: 52 weeks ]

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