Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

COPD

Treatments

Drug: Roflumilast

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00242320

BY217/M2-119

Details and patient eligibility

About

The aim of the study is to compare the effect of roflumilast on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of roflumilast.

Enrollment

551 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

Written informed consent
Patients with a history of chronic obstructive pulmonary disease (COPD) as defined by the GOLD criteria (2003)
FEV1/FVC ratio (post bronchodilator) smaller or equal 70%
FEV1 (post bronchodilator) 30-80% of predicted
Fixed airway obstruction
Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 10 pack years
Clinically stable COPD within 4 weeks prior to baseline visit
Availability of a chest x-ray

Main Exclusion Criteria:

COPD exacerbation indicated by a treatment with systemic glucocorticosteroids
Lower respiratory tract infection
Diagnosis of asthma
Known alpha-1-antitrypsin deficiency
Need for long term oxygen therapy defined as longer or equal 16 hours/day
Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
Known infection with HIV, active hepatitis and/or liver insufficiency (according to the Child Pugh score A or worse)
Diagnosis or history of cancer
Clinically significant cardiopulmonary abnormalities
Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
Female patients of childbearing potential, not using reliable method of contraception for the entire study duration, post-menopausal > 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases
Participation in another study (use of investigational product) within 30 days preceding the baseline visit or re-entry of patients already enroled in this trial
Alcohol or drug abuse
Inability to follow the study procedures due to e.g., language problems, physiological disorders
Use of not allowed drugs
Suspected hypersensitivity to the study medication or rescue medication