Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181272
Status:
TERMINATED
Last Update Posted:
2013-05-13
First Post:
2005-09-15
Brief Title:
Macrolides to Prevent Exacerbations of Asthma and Chronic Obstructive Pulmonary Disease
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Macrolides to Prevent Exacerbations of Asthma and Chronic Obstructive Pulmonary Disease
Status:
TERMINATED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator moved institutions
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 macrolide therapy is effective in treating patients hospitalized with asthma exacerbations or chronic obstructive pulmonary disease COPDexacerbations We hypothesize that compared to placebo maintenance therapy with macrolides when added to usual care a improves respiratory symptoms b improves quality of life c reduces airway inflammation d reduces airflow obstruction and e decreases the rate of re-exacerbations
Detailed Description:
Asthma and chronic obstructive pulmonary disease COPD are the two most common obstructive lung diseases Chronic airway inflammation and episodic worsening of respiratory symptoms and airflow obstruction exacerbations occur in asthma and COPD Despite major advances in the development of therapies for these respiratory disorders asthma and COPD exacerbations are common and result in substantial morbidity and mortality Moreover patients hospitalized for asthma or COPD exacerbations are at high risk for near fatal and fatal re-exacerbations after discharge home These observations highlight the need for novel therapies to prevent asthma and COPD exacerbations The role of macrolide antibiotics eg azithromycin clarithromycin erythromycin in treating bacterial infections is well established Recent pre-clinical evidence also suggests that macrolides may posses distinct anti-inflammatory properties and even anti-viral properties These exciting observations have led to research evaluating the use of maintenance therapy with macrolides in patients with asthma and COPD Small studies in clinically stable asthma or COPD suggest that maintenance macrolide therapy eg use for 6 weeks when added to usual care may attenuate airway inflammation reduce respiratory symptoms and improve lung function However there are no studies that have evaluated the potential benefits of initiating maintenance macrolide therapy during asthma or COPD exacerbations We hypothesize that initiating maintenance macrolide therapy in hospitalized patients with asthma or COPD exacerbations will when added to usual medical care accelerate the improvement in airflow obstruction respiratory symptoms and quality of life and reduce the risk of re-exacerbations after discharge home The objective of this pilot study is to evaluate the feasibility of the study protocol recruitment retention and adherence to study procedures and medications as well as collect preliminary data about the proportion of exacerbations due to bacterial or viral infections and estimate potential effect sizes for clinically important outcomes respiratory symptoms quality of life airflow obstruction airway inflammation and rate of re-exacerbations To achieve these objectives we propose a 48 week randomized double-blind placebo-controlled crossover clinical trial 24 weeks azithromycin 24 weeks placebo in adults hospitalized for asthma or COPD exacerbations to the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center
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