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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
511
ALTANA Pharma
Cities in Australia, Australia
ALTANA Pharma
Cities in Belgium, Belgium
ALTANA Pharma
Cities in France, France
ALTANA Pharma
Cities in South Africa, South Africa
ALTANA Pharma
Cities in Spain, Spain
mean change from randomization to endpoint in forced expiratory volume in one second.
forced expiratory vital capacity
peak expiratory flow
morning and evening peak expiratory flow (patient's diary)
symptom score and use of rescue medication (patient's diary)
Asthma Control Questionnaire (ACQ)
proportion of symptom-free days / rescue medication-free days asthma exacerbations.
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