Phase 3
Completed N=11
Enhancement of Corticosteroid Efficacy in COPD
Source: ClinicalTrials.gov NCT02340520 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: Bronchodilation — 1.18; 2.72; 1.22; 2.90 liters — p=>0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bronchodilation |
1.18; 2.72; 1.22; 2.90; 1.18; 2.72 | >0.05 |
| SECONDARY Change in HDAC2 Levels |
2.96; 2.58; 2.81 | >0.1 |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02340520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.