Enhancement of Corticosteroid Efficacy in COPD

NCT02340520 | Completed Phase 3 Results

• 1 other identifier: 14-032-3
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Bronchodilation

  Change in FEV1 L and FVC L

  Baseline, Week 1 and 2

Secondary Outcomes (1)

• Change in HDAC2 Levels

  Baseline, Week 1 and 2

Study Arms (1)

thophylline and roflumilast

EXPERIMENTAL

Theophylline for one week, followed by the addition of Roflumilast for a further one week.

Drug: Theophylline; Drug: Roflumilast

Interventions

Theophylline DRUG

Oral

thophylline and roflumilast

Roflumilast DRUG

Oral

thophylline and roflumilast

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of COPD with FEV1 \<60% predicted
• FEV1/FVC \<70% and \<+15% FEV1 response to bronchodilator.
• Patients of both genders will be included.
• IRB approved written informed consent will be obtained from each subject.

You may not qualify if:

• Recent (\<1 month) exacerbation of COPD,
• Known hypersensitivity to beta agonists, theophylline, steroids, or roflumilast.
• Current or recent (\<2 weeks) treatment with oral steroids, theophylline or other methylxanthines, or roflumlast.
• Diagnosis or history of asthma, uncontrolled hypertension, or congestive heart failure.
• History of Cardiac arrhythmia
• History of seizures.
• History of Liver disease
• Gastrointestinal disease, including history of peptic ulcer disease.
• Current infection or antibiotic treatment.
• History of depression or psychiatric disease.

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

UConnHealth

Farmington, Connecticut, 06032, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Theophylline; Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Nausherwan Burki, MD
• Organization: UConn Health

nburki@uchc.edu

Study Officials

• Nausherwan Burki

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Study Start: December 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 19, 2018
• Results First Posted: June 19, 2018

Record last verified: 2018-05

Locations

US (1)