Enhancement of in−Vitro GC Function in Patients With COPD
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|ClinicalTrials.gov Identifier: NCT00241631|
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : May 28, 2015
The global burden of COPD − a common and debilitating chronic inflammatory disease that is characterised by the progressive development of airflow limitation (shortness of breath − SOB) and is poorly reversible with currently available drugs −is increasing. Cigarette smoking is strongly linked with the ongoing inflammation; inflammation that can continue even when the patient has stopped smoking. The severity of airflow limitation (SOB) is correlated with the degree of pulmonary (lung) inflammation.
Histone deacetylases (HDACs)are important molecules in suppressing this pulmonary inflammation. We have recently shown that patients with COPD have a reduction in total HDAC which correlates with the severity of their lung disease.
Corticosteroids (anti−inflammatory treatment) act, at least in part, by recruitment of these HDACs to the site of active inflammatory gene transcription (which reduces the production of inflammatory molecules) and are widely used in COPD in patients with severe disease. Unfortunately, in COPD, inhaled corticosteroids seem to have little effect on the underlying inflammation (though in a selective group of patients with COPD they do reduce the number of infections a patient may have by a small amount). Theophylline has been used in the treatment of asthma and COPD for over 70 years, but its use has recently declined. Data so far obtained in primary cells (cells from patients used in the laboratory) from COPD patients suggests that low dose theophylline (~5mg/l) should be effective in restoring steroid sensitivity in patients with COPD (and hence reduce inflammation thus improving SOB). We wish therefore to continue these studies on theophylline principally by conducting a small clinical pilot study on 20−30 COPD patients in a randomised, double−blind, placebo−controlled, parallel−group study.
|Condition or disease||Intervention/treatment||Phase|
|COPD||Drug: fluticasone Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Enhancement of In-vitro GC Function in Patients With COPD. A Randomised, Double Blind, Placebo Controlled, Parallel-group Study to Investigate the Effect of Theophylline and Fluticasone on Induced Sputum Cells Obtained Form COPD Patients|
|Study Start Date :||April 2006|
|Actual Study Completion Date :||August 2007|
|Active Comparator: 1||
500 mg b.d.
|Placebo Comparator: 2||
- sputum inflammatory cell counts [ Time Frame: 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241631
|Windsor chest clinic KEVII Hospital|
|Windsor, Berks, United Kingdom, SL4 3DP|
|Principal Investigator:||ian adcock, PhD||Imperial College London|