Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00132860
• Other study ID #: ProToCOL
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 19, 2005
• Last updated: October 18, 2005
• Start date: May 2001
• Est. completion date: December 2007

Study information

• Verified date: August 2005
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• azithromycin

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?change in postbronchodilator FEV1
Secondary	number of hospital admissions and number of hospital days
Secondary	mortality
Secondary	quality of life
Secondary	use of medication
Secondary	prevalence of respiratory pathogens
Secondary	prevalence of macrolide resistance
Secondary	inflammatory parameters