Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

September 26, 2008 updated by: Medical Center Alkmaar

The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients

The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.

The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

258

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

  • Netherlands
    • Noord-holland
      • Alkmaar, Noord-holland, Netherlands, 1815 JD
        • Medisch Centrum Alkmaar

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute exacerbation of COPD type I or II according to GOLD
  • Ability to perform lung function tests
  • Ability to take oral medication

Exclusion Criteria:

  • Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
  • Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation.
  • Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation.
  • Progression or new radiographic abnormalities on the chest X-ray.
  • Severe exacerbation that required mechanical ventilation.
  • History of bronchiectasis
  • Recent or unresolved lung malignancy.
  • Other disease likely to require antibiotic therapy.
  • Significant gastrointestinal or other conditions that may affect study drug absorption.
  • Class III or IV congestive heart failure or stroke.
  • Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks).
  • Cystic fibrosis
  • Tuberculosis.
  • Impaired renal function (creatinine clearance < 20 ml/min).

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: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical efficacy at the end of treatment

Secondary Outcome Measures

Outcome Measure
Treatment failure at follow up
Number of exacerbation

Collaborators and Investigators

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

Sponsor

Medical Center Alkmaar

Investigators

  • Principal Investigator: Johannes MA Daniels, drs, Pulmo Science

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

July 1, 2002

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 29, 2008

Last Update Submitted That Met QC Criteria

September 26, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-007

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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