Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147667
Status:
UNKNOWN
Last Update Posted:
2005-09-07
First Post:
2005-09-02
Brief Title:
Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD
Sponsor:
Royal Free and University College Medical School
Organization:
Royal Free and University College Medical School
Study Overview
Official Title:
Randomised Double Blind Placebo Controlled Trial of Effects of Long Term Low Dose Oral Erythromycin Therapy in Patients With Chronic Obstructive Pulmonary Disease
Status:
UNKNOWN
Status Verified Date:
2004-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 purpose of this study is to determine whether long term treatment with oral erythromycin is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease COPD by reducing the number of exacerbations and the degree of airway inflammation
Detailed Description:
COPD is characterised by persisting airway inflammation which leads to a progressive and irreversible deterioration in lung function with the eventual development of respiratory symptoms which may become disabling Periodic episodes of worsening symptoms or exacerbations are a major cause of additional morbidity mortality and health care utilization Currently available therapies have limited efficacy in reducing airway inflammation or preventing exacerbations
Macrolides such as erythromycin have been shown to have potent anti-inflammatory effects in in vitro experiments and in other lung conditions such as cystic fibrosis and bronchiectasis as well as in open label studies in COPD We hypothesised that long term therapy with oral erythromycin would reduce airway inflammation and reduce the frequency of exacerbations in patients with COPD If these properties are demonstrated this therapy can have potentially important benefits if effective in this condition
Macrolides such as erythromycin have been shown to have potent anti-inflammatory effects in in vitro experiments and in other lung conditions such as cystic fibrosis and bronchiectasis as well as in open label studies in COPD We hypothesised that long term therapy with oral erythromycin would reduce airway inflammation and reduce the frequency of exacerbations in patients with COPD If these properties are demonstrated this therapy can have potentially important benefits if effective in this condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None