Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)
Completed · Phase 3
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT00163527
- Run by
- AstraZeneca
- People needed
- 2054
- Starts
- 2003-04-01
- Expected to finish
- 2005-11-01
- Last updated by the study team
- 2016-12-02
Who can join
Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- ALTANA Pharma — Cities in Italy, Italy
- ALTANA Pharma — Cities in New Zealand, New Zealand
- ALTANA Pharma — Cities in Norway, Norway
- ALTANA Pharma — Cities in Pakistan, Pakistan
- ALTANA Pharma — Cities in the Philippines, Philippines
- ALTANA Pharma — Cities in Poland, Poland
- ALTANA Pharma — Cities in Portugal, Portugal
- ALTANA Pharma — Cities in the Russian Federation, Russia
- ALTANA Pharma — Sites in Singapore, Singapore
- ALTANA Pharma — Cities in South Africa, South Africa
- ALTANA Pharma — Cities in Spain, Spain
- ALTANA Pharma — Cities in Taiwan, Taiwan
- ALTANA Pharma — Cities in Thailand, Thailand
- ALTANA Pharma — Cities in the United Kindom, United Kingdom
Full record on ClinicalTrials.gov
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