TREAT
Research type
Research Study
Full title
Effect of roflumilast 500 µg tablets once daily at acute COPD exacerbations treated with standard therapy of oral steroids and antibiotics. A randomised, double-blind, placebo-controlled, parallel-group trial.
IRAS ID
91966
Contact name
Jadwiga Wedzicha
Sponsor organisation
Nycomed GmbH
Eudract number
2011-002905-31
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
This is a randomised, double-blind, parallel-group, mono-centre, phase II trial. Eligible COPD patients, recruited from the Royal Free Hospital London COPD patient cohort, must present with an acute exacerbation at inclusion and will be randomised 1:1 to either fluilast 500 mg or placebo, od. Treatment period will be 4 weeks followed by a follow-up period of another 4 weeks. Patients will be allowed to continue standard COPD treatment during the treatment and follow-up period, and will receive a standardised exacerbation treatment (oral corticosteroids for 10 days and antibiotics for 7 days). Clinic visits will be performed at Days 1 (Visit V0, inclusion and randomisation), 7 (Visit V1), 14 (Visit V2), 28 (Visit V3) and 56 (Follow-up Visit VFU). During the entire trial period patients will keep diaries on which they record their morning post-medication peak expiratory flow (PEF) and any increase in their daily respiratory symptoms. Additionally, patient-reported outcomes (COPD Assessment Test [CAT], EXAcerbations of Chronic pulmonary disease Test. Patient-Reported Outcome [EXACT-PRO]) will be recorded daily. Diaries and questionnaires, routinely completed in the Royal Free Hospital London COPD cohort, will also be retrospectively collected from Day -14 onwards. At clinic visits pulmonary function tests will be performed, and sputum and blood will be collected to assess a variety of biomarkers.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
11/SC/0494
Date of REC Opinion
24 Nov 2011
REC opinion
Favourable Opinion