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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,054
ALTANA Pharma
Cities in Georgia, Georgia, United States
ALTANA Pharma
Cities in Austria, Austria
ALTANA Pharma
Cities in Croatia, Croatia
ALTANA Pharma
Cities in the Czech Repulik, Czechia
ALTANA Pharma
Cities in Finland, Finland
ALTANA Pharma
Cities in France, France
ALTANA Pharma
Cities in Greece, Greece
ALTANA Pharma
Cities in Hungary, Hungary
ALTANA Pharma
Cities in India, India
ALTANA Pharma
Cities in Ireland, Ireland
...and 14 more locations
change in forced expiratory volume in 1 second from baseline to final visit.
change from baseline to each visit for spirometry variables, forced vital capacity, mean expiratory flow, peak expiratory flow
change from baseline to each visit based on diary data variables (asthma symptom scores: daytime, nighttime, and summary, use of rescue medication, diurnal variability)
number of rescue free/symptom free days based on the diary card
area under the curves over the full 24-week trial period for the diary variables
number of exacerbations
time to first exacerbation
change from baseline according to the Asthma Quality of Life Questionnaire (AQLQ).
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