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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: azithromycin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. change in postbronchodilator FEV1

Secondary Outcome Measures :
  1. number of hospital admissions and number of hospital days
  2. mortality
  3. quality of life
  4. use of medication
  5. prevalence of respiratory pathogens
  6. prevalence of macrolide resistance
  7. inflammatory parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00132860

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Odense University Hospital
Odense, Denmark, 5000 C
Sponsors and Collaborators
Odense University Hospital
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Principal Investigator: Svend S Pedersen Odense University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00132860     History of Changes
Other Study ID Numbers: ProToCOL
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: October 19, 2005
Last Verified: August 2005
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents