Enhancement of Corticosteroid Efficacy in COPD
Completed · Phase 3
Conditions studied: COPD
In brief
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 facts
- Study ID
- NCT02340520
- Run by
- UConn Health
- People needed
- 13
- Starts
- 2014-12-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2018-06-19
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- UConnHealth — Farmington, Connecticut, United States
Full record on ClinicalTrials.gov
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