CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,523 enrolled
Drug / intervention
Roflumilast +1 moredrug
Likely dose
Roflumilast 500 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00297102
NCT00297102Phase 3Completed
CompareCT.gov

Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study

AstraZeneca·interventional·Posted Feb 28, 2006·Updated Jan 16, 2017

In Brief

A Phase 3 clinical trial evaluating Roflumilast and Placebo for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 1,523 participants across 179 sites in 11 countries.

Detailed Summary

The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast. For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesAustralia, Austria, Brazil, France, Germany, Hungary, New Zealand, Romania, Russia, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 28, 2006
Enrollment StartFeb 1, 2006
Primary CompletionJul 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.3 years ago

Interventions

Roflumilastdrug

500 mcg, once daily, oral administration in the morning

Placebodrug

once daily