Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD) - Full Text View

Sponsored by:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00132860

Purpose

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	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: azithromycin	Phase IV

MedlinePlus related topics: Antibiotics COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Azithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
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

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

change in postbronchodilator FEV1

Secondary Outcome Measures:

number of hospital admissions and number of hospital days
mortality
quality of life
use of medication
prevalence of respiratory pathogens
prevalence of macrolide resistance
inflammatory parameters

Estimated Enrollment:	800
Study Start Date:	May 2001
Estimated Study Completion Date:	December 2007

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients above 50 years of age, with a current admission for exacerbation of COLD or at least one admission within the previous two years.
Current or ex-smoker
Postbronchodilator FEV1 < 60% in stable condition (> 4 weeks after hospitalisation)
< 300 ml bronchodilator reversibility in FEV1

Exclusion Criteria:

Patients with end-stage COLD, who are not expected to survive for 3 years (typically bedridden patients being dyspnoeic in rest).
Patients with known other respiratory tract infection, e.g. tuberculosis or aspergillosis, in whom the intervention is known to be inefficient.
Patients with pulmonary malignancy
Patients with other pulmonary diseases than COLD.
Patients with immunodeficiency. However, COLD patients treated with steroids can be included.
Patients with known hereditary disposition to lung infections such as alfa-1-antitrypsin deficiency, cystic fibrosis or primary ciliary dyskinesia.
Patients receiving longterm antibiotic treatment ( e.g. recurrent cystitis).
Patients with known allergy or intolerance to azithromycin
Pregnant or breastfeeding women
Manifest heart, liver or renal insufficiency
Patients that, for reasons not stated above, are unlikely to be able to participate in a study period of 3 years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132860

Locations

Denmark
Odense University Hospital
Odense, Denmark, 5000 C

Sponsors and Collaborators

Odense University Hospital

Investigators

Principal Investigator:

Svend S Pedersen

Odense University Hospital

More Information

No publications provided

Study ID Numbers:	ProToCOL
Study First Received:	August 19, 2005
Last Updated:	October 18, 2005
ClinicalTrials.gov Identifier:	NCT00132860 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Anti-Bacterial Agents
Lung Diseases, Obstructive
Respiratory Tract Diseases
Azithromycin

Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

Therapeutic Uses
Azithromycin
Lung Diseases
Chronic Disease
Pharmacologic Actions
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009