Asthma Clinical Trial
Official title:
A 24-Week, Double-Blind, Parallel Group, Placebo and Active Controlled Study to Investigate the Efficacy and Safety of Daily Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Chronic Asthma
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 investigate the effect of roflumilast taken orally together with
low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one
dose level once daily together with inhaled corticosteroids at one dose level twice daily.
The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24
weeks). The study will provide further data on safety, tolerability, and effectiveness of
roflumilast.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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