Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132860
Status:
UNKNOWN
Last Update Posted:
2005-10-19
First Post:
2005-08-19
Brief Title:
Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease COLD
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease A Prospective Randomized Double-Blind Placebo-Controlled Study of Intermittent Prophylactic Antibiotic Treatment With Azithromycin
Status:
UNKNOWN
Status Verified Date:
2005-08
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 the study is to investigate in patients with moderate to severe chronic obstructive lung disease whether intermittent antibiotic treatment leads to
A slower rate of decline in forced expiratory volume in one second FEV1
A reduction in the frequency and severity of exacerbations
Fewer hospital admissions for chronic obstructive pulmonary disease COPD
Lower mortality
An improved quality of life as compared to a group of placebo treated patients
A slower rate of decline in forced expiratory volume in one second FEV1
A reduction in the frequency and severity of exacerbations
Fewer hospital admissions for chronic obstructive pulmonary disease COPD
Lower mortality
An improved quality of life as compared to a group of placebo treated patients
Detailed Description:
Study Population Patients with moderate to severe chronic obstructive lung disease
Trial Phase IV
Study Design Prospective randomised double-blind placebo- controlled clinical trial
Study Medicine Azithromycin
Drug Administration Oral
Drug Dose 500 mg once daily for 3 days every month
Duration of Treatment 3 years
Number of Evaluable Patients 200 per treatment arm
Number of Included Patients 400 per treatment arm 800 patients in total
Trial Phase IV
Study Design Prospective randomised double-blind placebo- controlled clinical trial
Study Medicine Azithromycin
Drug Administration Oral
Drug Dose 500 mg once daily for 3 days every month
Duration of Treatment 3 years
Number of Evaluable Patients 200 per treatment arm
Number of Included Patients 400 per treatment arm 800 patients in total
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