Loading clinical trials...

Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)

Effect of Roflumilast in COPD Patients Treated With Salmeterol. A 24-week, Double-blind Study With 500 μg Roflumilast Once Daily Versus Placebo. The EOS Study

NCT00313209•AstraZeneca

View on ClinicalTrials.gov

Summary

The aim of the study is to compare the efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•History of COPD for at least 12 months prior to baseline visit
•FEV1/FVC ratio (post-bronchodilator) ≤ 70%
•FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted

Exclusion Criteria

•COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit

Locations (134)

Altana Pharma/Nycomed Investigational Site

Linz, Austria

Altana Pharma/Nycomed Investigational Site

Neusiedl/See, Austria

Altana Pharma/Nycomed Investigational Site

Perg, Austria

Altana Pharma/Nycomed Investigational Site

Salzburg, Austria

Altana Pharma/Nycomed Investigational Site

Sankt Pölten, Austria

Altana Pharma/Nycomed Investigational Site

Steyr, Austria

Altana Pharma/Nycomed Investigational Site

Vienna, Austria

Altana Pharma/Nycomed Investigational Site

Vienna, Austria

Altana Pharma/Nycomed Investigational Site

Vienna, Austria

Altana Pharma/Nycomed Investigational Site

Wiener Neustadt, Austria

Key Dates

Start Date

April 1, 2006

Primary Completion Date

July 1, 2007

Completion Date

February 1, 2008

Last Updated

December 14, 2016

Enrollment

933

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Roflumilast

DRUG

Placebo

DRUG

Sponsors

Lead Sponsor

AstraZeneca

Related Studies

RECRUITINGPHASE1/PHASE2

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

NCT07382258

Chronic Obstructive Pulmonary Disease (COPD)

Mindful-Breath for People With COPD

NCT07195838

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions