Enhancement of in−Vitro GC Function in Patients With COPD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00241631|
Recruitment Status : Completed
First Posted : October 19, 2005
Results First Posted : December 4, 2019
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|COPD||Drug: Fluticasone Propionate Drug: placebo Drug: Theophylline||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 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|
|Actual Study Start Date :||April 2006|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
Placebo Comparator: Placebo
Inhaled Theophylline placebo capsule, then placebo, then active Theophylline
Theophylline placebo capcule
Active Comparator: Steroid
Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline
Drug: Fluticasone Propionate
Theophylline placebo capcule
- Sputum Inflammatory Cell Counts [ Time Frame: 10 weeks ]Supernatant collect, cell pellets count on slides
- Interleukin 8 (IL8) [ Time Frame: 10 weeks ]Interleukin 8 (IL8) assessed from sputum
- Total Sputum Eosinophils [ Time Frame: 10 weeks ]Total eosinophils cells assessed from sputum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|