CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 158 enrolled
Drug / intervention
Roflumilast +1 moredrug
Likely dose
Roflumilast 500 μgfrom 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/NCT01509677
NCT01509677Phase 3Completed
CompareCT.gov

A 16-week, Randomized, Placebo-controlled, Double Blind, and Parallel Group Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease

AstraZeneca·interventional·Posted Jan 13, 2012·Updated Nov 29, 2019

In Brief

A Phase 3 clinical trial evaluating Roflumilast and Placebo for COPD and Chronic Obstructive Pulmonary Disease. Completed, enrolled 158 participants across 20 sites in 5 countries.

Detailed Summary

The objective of the Biopsy trial is to investigate the effect of roflumilast 500 µg tablets once daily versus placebo on inflammation parameters in bronchial biopsy tissue specimen and additional in sputum and blood serum. Also data on safety status will be obtained. Patients to be included required to have moderate to severe COPD associated with chronic bronchitis. The total duration of this randomized, multicentre, phase III trial is 24 weeks maximum.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD, Chronic Obstructive Pulmonary Disease
CountriesDenmark, Germany, Poland, Sweden, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2012
Enrollment StartFeb 1, 2012
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 14.5 years ago

Interventions

Roflumilastdrug

500 μg tablet, once daily, oral administration in the morning after breakfast

Placebodrug

tablet, once daily, oral administration in the morning after breakfast