Enhancement of Corticosteroid Efficacy in COPD

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
UConn Health
Study ID
NCT02340520
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 31, 2014
Status verified
May 2018
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: thophylline and roflumilast
    Theophylline for one week, followed by the addition of Roflumilast for a further one week.

Primary Outcome Measure

Bronchodilation [ Time Frame: Baseline, Week 1 and 2 ]

Locations (1)

FacilityCityStateZIPSite coordinators
UConnHealthFarmingtonConnecticut06032-

Find similar trials in Farmington, CT

By condition
COPD
By specialty
PulmonologyLung disease
By research site
UConnHealth· Farmington, CT

Related Studies