Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00062582

Enrollment

1000

Registered

2003-06-10

Start date

2003-06-30

Completion date

Unknown

Last updated

2016-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, COPD

Keywords

Roflumilast, Chronic Obstructive Pulmonary Disease, COPD

Brief summary

The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.

Interventions

DRUGRoflumilast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: * Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease) * Currently stable COPD with no change in COPD treatment in the prior 4 weeks Main

Exclusion criteria

* Clinical diagnosis of asthma * Poorly controlled COPD * Regular need for daily oxygen therapy

Design outcomes

Primary

Measure	Time frame
pulmonary function.	—

Secondary

Measure	Time frame
exacerbation rate	—
quality of life	—
symptoms	—
use of rescue medication	—
safety and tolerability.	—

Countries

Argentina, Canada, Colombia, Mexico, Peru, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026