Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00241631
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2005-10-18
Brief Title:
Enhancement of in-Vitro GC Function in Patients With COPD
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigator 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
Detailed Description:
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 HDACsare 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 5mgl should be effective in restoring steroid sensitivity in patients with COPD and hence reduce inflammation thus improving SOB
Histone deacetylases HDACsare 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 5mgl should be effective in restoring steroid sensitivity in patients with COPD and hence reduce inflammation thus improving SOB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None