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Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

NCT00424268 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 743

Last updated 2016-12-05

Study results available
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Summary

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

Conditions

Interventions

DRUG

Roflumilast

500 µg, once daily, oral administration in the morning

DRUG

Placebo

once daily

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca AstraZeneca · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-01-31
Completion
2008-07-31

Countries

  • Austria
  • France
  • Germany
  • Hungary
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00424268 on ClinicalTrials.gov