Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325897
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2006-05-12
Brief Title:
Macrolide Azithromycin to Prevent Rapid Worsening of Symptoms Associated With Chronic Obstructive Pulmonary Disease
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Effect of Chronic Macrolide Administration on the Frequency and Severity of COPD Exacerbations
Status:
COMPLETED
Status Verified Date:
2019-10
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 purpose of this study is to determine if long-term administration of a macrolide antibiotic will reduce worsening of symptoms among individuals with chronic obstructive pulmonary disease COPD
Detailed Description:
BACKGROUND
The prevalence morbidity mortality and treatment cost of COPD are high and increasing COPD is the sixth leading cause of death worldwide and is the only condition in the top 10 causes of death that has an increasing prevalence and mortality The cost of health care for patients with COPD in the US is approximately 65 billion per year acute exacerbations account for between 31 and 68 of that cost Macrolide antibiotics may reduce the frequency andor severity of COPD exacerbations as a result of their antibacterial properties and anti-inflammatory effects Long-term administration of macrolide antibiotics in patients with a number of other pulmonary disorders has resulted in clinically important improvements It is hypothesized that administration of a macrolide antibiotic azithromycin for 1 year when added to usual care will decrease the frequency and severity of COPD exacerbations If this hypothesis is correct the proposed treatment is also expected to reduce the mortality of COPD patients
DESIGN NARRATIVE
This is a prospective randomized double-blind placebo-controlled study that will enroll 1130 patients with at least moderately severe COPD who based on clinical indicators have an increased likelihood of experiencing an acute exacerbation during the study period Patients will be monitored monthly including careful assessments of possible macrolide-related side effects The exclusion criteria for this study will include a variety of conditions or medications that are known to adversely interact with macrolides The primary endpoint of this study is time until the first acute COPD exacerbation The secondary endpoints include macrolide-related side effects the incidence of macrolide-resistant bacterial colonization quality of life and cost-effectiveness
The prevalence morbidity mortality and treatment cost of COPD are high and increasing COPD is the sixth leading cause of death worldwide and is the only condition in the top 10 causes of death that has an increasing prevalence and mortality The cost of health care for patients with COPD in the US is approximately 65 billion per year acute exacerbations account for between 31 and 68 of that cost Macrolide antibiotics may reduce the frequency andor severity of COPD exacerbations as a result of their antibacterial properties and anti-inflammatory effects Long-term administration of macrolide antibiotics in patients with a number of other pulmonary disorders has resulted in clinically important improvements It is hypothesized that administration of a macrolide antibiotic azithromycin for 1 year when added to usual care will decrease the frequency and severity of COPD exacerbations If this hypothesis is correct the proposed treatment is also expected to reduce the mortality of COPD patients
DESIGN NARRATIVE
This is a prospective randomized double-blind placebo-controlled study that will enroll 1130 patients with at least moderately severe COPD who based on clinical indicators have an increased likelihood of experiencing an acute exacerbation during the study period Patients will be monitored monthly including careful assessments of possible macrolide-related side effects The exclusion criteria for this study will include a variety of conditions or medications that are known to adversely interact with macrolides The primary endpoint of this study is time until the first acute COPD exacerbation The secondary endpoints include macrolide-related side effects the incidence of macrolide-resistant bacterial colonization quality of life and cost-effectiveness
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10HL074424-03 | NIH | None | httpsreporternihgovquickSearchU10HL074424-03 |