Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.
Data Collection
Chronic Disease+4
+ Lung Diseases
+ Lung Diseases, Obstructive
Treatment Study
Summary
Study start date: December 1, 2003
Actual date on which the first participant was enrolled.The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Main Inclusion Criteria: * FEV1/FVC ratio (post-bronchodilator) ≤70% * FEV1 (post-bronchodilator) ≤50% of predicted * Current smoker or ex-smoker * Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline * Availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline Main Exclusion Criteria: * COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline * Lower respiratory tract infection not resolved 4 weeks prior to baseline * Diagnosis of asthma and/or other relevant lung disease * Known alpha-1-antitrypsin deficiency * Need for long-term oxygen therapy defined as ≥16 hours/day
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 40 locations
ALTANA Pharma
Cities in Arizona, United StatesALTANA Pharma
Cities in Arkansas, United StatesALTANA Pharma
Cities in California, United States