Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)

Sponsor
AstraZeneca
Study ID
NCT00163475
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma. The aim of the study is to compare the effect of roflumilast on lung function, symptoms, and use of rescue medication in patients with stable asthma. Roflumilast will be administered orally either in the morning or in the evening at one dose level. The study duration consists of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

Key Dates

Start date
May 31, 2004
Status verified
Sep 2016
Primary completion
Aug 31, 2005
Completion
Aug 31, 2005

Study Design

Enrollment
511 participants
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

mean change from randomization to endpoint in forced expiratory volume in one second.

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