Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Roflumilast

Study type

Interventional

Funder types

Industry

Identifiers

NCT00163475

BY217/M2-015

Details and patient eligibility

About

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.

Sex

All

Ages

12 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

Written informed consent
Diagnosis of persistent bronchial asthma (with reference to the Global Initiative for Asthma Guidelines 2002)
Baseline FEV1 50 - 85% in patients either untreated or receiving e.g. short-acting bronchodilators, DSCG, nedocromil, anticholinergics, long-acting bronchodilators, theophylline/aminophylline, lipoxygenase inhibitors, leukotriene antagonists, alone or in combination
Baseline FEV1 60 - 90% in patients receiving not more than 500 mcg BDP-CFC (or equivalent) and/or in combination with any other asthma medication mentioned above
No change in the asthma treatment 4 weeks prior to baseline period
Patients who, with the exception of asthma, are in good health

Main Exclusion Criteria:

Poorly controlled asthma: requirement of a course of oral and/or parenteral glucocorticosteroids 4 weeks prior to the baseline, or admission to hospital for asthma (including treatment in an emergency room) 4 weeks prior to the baseline period, or asthma exacerbation in the last 4 weeks prior to baseline period
Patient using regularly >8 puffs/day rescue medication prior to baseline
History of lower airway infection in the last 4 weeks prior to baseline period
Diagnosis of chronic obstructive pulmonary disease and/or other relevant lung diseases
Heavy smoker: currently: >20 cigarettes/day and/or >10 pack years, ex-smoker: with a smoking history of ≥10 pack years
Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
Liver insufficiency (Child Pugh A or worse)
Active hepatitis
Known infection with HIV
Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start
Alcohol and/or drug abuse
Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
Pregnancy or patient of childbearing potential who is not using reliable method of contraception
Patients not able to follow study procedures, e.g. due to language problems, psychological disorders
Suspected inability or unwillingness to comply with the study procedures