Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT00132860
Status:
UNKNOWN
Last Update Posted:
2005-10-19
First Post:
2005-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)
Sponsor:
Odense University Hospital
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: