drugset / Trial / NCT02340520

Enhancement of Corticosteroid Efficacy in COPD

NCT02340520

Phase 3 Completed 13 enrolled UConn Health
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-12
Primary completion
2016-08
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Roflumilast Small molecule 500 ug Oral
Subject Theophylline Small molecule 300 mg Oral