CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 13 enrolled
Drug / intervention
Theophylline +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/NCT02340520
NCT02340520Phase 3Completed
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Enhancement of Corticosteroid Efficacy in COPD

UConn Health·interventional·Posted Jan 16, 2015·Updated Jun 19, 2018

In Brief

A Phase 3 clinical trial evaluating Theophylline and Roflumilast for COPD. Completed, enrolled 13 participants across 1 site.

Detailed Summary

This is a pilot study designed to evaluate the effects of theophylline and roflumilast on circulating Histone deacetylase (HDAC) levels in subjects with COPD, and the bronchodilator effects of corticosteroids. Studies will be performed in 10 subjects with COPD nonresponsive to bronchodilators. Subjects will receive theophylline tablets for 1 week, followed by measurement of circulating HDAC and the acute effect of oral prednisone on the bronchodilator response to inhaled beta agonist. Roflumilast tablets will be added to the theophylline for a further week and the studies repeated. The study will provide preliminary data on the effects of theophylline and roflumilast on circulating HDAC levels and the effects of corticosteroids on the beta agonist bronchodilator response in COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 16, 2015
Enrollment StartDec 1, 2014
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.5 years ago

Interventions

Theophyllinedrug

Oral

Roflumilastdrug

Oral