CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Roflumilast Placebo +1 moredrug
Likely dose
Not stated in 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/NCT02097992
NCT02097992Phase 2Completed
CompareCT.gov

Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD

University of Miami·interventional·Posted Mar 27, 2014·Updated Nov 24, 2017

In Brief

A Phase 2 clinical trial evaluating Roflumilast Placebo and Roflumilast for COPD. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The objectives of the proposed study are to determine 1) the effect of a single dose of Roflumilast on airway blood flow (Qaw) (study period 1) and 2) the effect of long-term Roflumilast treatment on airway blood flow reactivity delta Qaw)(study period 2) in patients with stable COPD who use ICS regularly.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 27, 2014
Enrollment StartFeb 1, 2013
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.3 years ago

Interventions

Roflumilast Placebodrug

Placebo pill

Roflumilastdrug

500 Ug ORAL TABLET