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

NCT ID: NCT00132860

Last Updated: 2005-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2007-12-31

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.

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

azithromycin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Svend S Pedersen

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Odense University Hospital

Odense, , Denmark

Countries

Denmark

References

Sorensen AK, Holmgaard DB, Mygind LH, Johansen J, Pedersen C. Neutrophil-to-lymphocyte ratio, calprotectin and YKL-40 in patients with chronic obstructive pulmonary disease: correlations and 5-year mortality - a cohort study. J Inflamm (Lond). 2015 Mar 18;12:20. doi: 10.1186/s12950-015-0064-5. eCollection 2015.

Reference Type: DERIVED

PMID: 25908927 (View on PubMed)

Holmgaard DB, Mygind LH, Titlestad IL, Madsen H, Pedersen SS, Johansen JS, Pedersen C. Plasma YKL-40 and all-cause mortality in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2013 Dec 30;13:77. doi: 10.1186/1471-2466-13-77.

Reference Type: DERIVED

PMID: 24373580 (View on PubMed)

Other Identifiers

ProToCOL

Identifier Type: -

Identifier Source: org_study_id