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

October 18, 2005 updated by: Odense University Hospital

Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease: A Prospective, Randomized, Double-Blind Placebo-Controlled Study of Intermittent, Prophylactic Antibiotic Treatment With Azithromycin

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

800

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000 C
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
change in postbronchodilator FEV1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Svend S Pedersen, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

August 19, 2005

First Submitted That Met QC Criteria

August 19, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

October 19, 2005

Last Update Submitted That Met QC Criteria

October 18, 2005

Last Verified

August 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProToCOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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