Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)

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.

Main Inclusion Criteria:

• Written informed consent
• Diagnosis of persistent chronic bronchial asthma, according to Global Initiative for Asthma (GINA) guidelines
• The patient has been receiving BDP - CFC ≤1000 mcg per day or equivalent for the previous four weeks
• FEV1 between 60 and 90% predicted at visit 1
• No change in asthma treatment within 4 weeks prior to visit 1

Main Exclusion Criteria:

• Patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1
• Patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period
• A history of lower airway infection in the four weeks prior to visit 1
• A diagnosis of chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis)
• Heavy smoker currently smoking >20 cigarettes per day and/or >10 pack years or the patient is an ex-smoker who has smoked >10 pack years
• Patients using >8 puffs/day relief medication regularly prior to visit 1
• Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
• A diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
• Patients with chronic heart failure class III or IV (New York Heart Association)
• Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, BDP, or salbutamol)
• A history of alcoholism or substance abuse within the 12 months prior to visit 1
• Pregnancy or women of childbearing potential who are not using a reliable method of contraception