Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)
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|ClinicalTrials.gov Identifier: NCT00132860|
Recruitment Status : Unknown
Verified August 2005 by Odense University Hospital.
Recruitment status was: Active, not recruiting
First Posted : August 22, 2005
Last Update Posted : October 19, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: azithromycin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||800 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||May 2001|
|Study Completion Date :||December 2007|
- change in postbronchodilator FEV1
- number of hospital admissions and number of hospital days
- quality of life
- use of medication
- prevalence of respiratory pathogens
- prevalence of macrolide resistance
- inflammatory parameters
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132860
|Odense University Hospital|
|Odense, Denmark, 5000 C|
|Principal Investigator:||Svend S Pedersen||Odense University Hospital|