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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Roflumilast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Roflumilast|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in forced expiratory volume in 1 second from baseline to final visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Roflumilast, Corticosteroids