Completed

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.

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What is being tested

Data Collection

Who is being recruted

Chronic Disease+4

+ Lung Diseases

+ Lung Diseases, Obstructive

Over 40 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

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).

Official TitleEffect 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. 
NCT00076089
Principal SponsorAstraZeneca
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesDisease AttributesPulmonary Disease, Chronic Obstructive

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

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

Suspended

ALTANA Pharma

Cities in Alabama, United StatesSee the location
Suspended

ALTANA Pharma

Cities in Arizona, United States
Suspended

ALTANA Pharma

Cities in Arkansas, United States
Suspended

ALTANA Pharma

Cities in California, United States
Completed40 Study Centers