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Antibiotics in Chronic Obstructive Pulmonary Disease (COPD) (TAExaCOP)

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ClinicalTrials.gov Identifier: NCT00952861
Recruitment Status : Withdrawn (Stopped due to poor recruitment)
First Posted : August 6, 2009
Last Update Posted : August 11, 2010
Information provided by:

Study Description
Brief Summary:
It is not clear whether antibiotic therapy is needed in patients with mild to moderate exacerbation of chronic obstructive lung disease. The aim of the study is to compare the effect of 1 day of treatment with 6 days of treatment in patients who are admitted to hospital and being clinical stable (as judged by their physician) 24 hours after hospitalization

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Doxycycline Drug: Placebo (matching) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antibiotic Treatment of Patients Admitted to Hospital With Acute Exacerbation of COPD. Effect of 1 Day of Antibiotic Therapy Compared to 6 Days of Therapy in Patients Who Are Stable After 24 Hours
Study Start Date : October 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : December 2010

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Doxycycline
Doxycycline 200 mg QD in 5 days
Drug: Doxycycline
200 mg QD in 5 days
Placebo Comparator: Placebo
Matching placebo QD i 5 days
Drug: Placebo (matching)
Placebo QD i 5 days

Outcome Measures

Primary Outcome Measures :
  1. 6 minutes walking distance [ Time Frame: Day 14 ]

Secondary Outcome Measures :
  1. Time to next episode of acute exacerbation [ Time Frame: Days 14, 30, 90 and 180 ]

Eligibility Criteria

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

Inclusion Criteria:

  • Age above 50 years
  • History of smoking
  • History of COPD
  • Antibiotics for 24 hours
  • At least 2 of the following: dyspnoea, coughing with sputum, and sputum with purulence
  • Informed consent

Exclusion Criteria:

  • Pneumonia
  • Antibiotics for more than 36 hours
  • Antibiotics for other infection
  • Prednisolone, more than 0.5 mg/kg body weight/24 hours for more than 3 days
  • Malignancy
  • Other pulmonary disease
  • Immune deficiency
  • Not able to tolerate doxycycline
  • Severe heart, liver or kidney disease
  • Epilepsia
  • Not stable 24 hours after hospital admission
  • Need for assisted ventilation
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00952861

Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Kolding Sygehus
Svendborg Hospital
Fredericia Hospital
Naestved Hospital
Hillerod Hospital, Denmark
Region Syddanmark
Danmarks Lungeforening
Danish National Research Foundation
Study Chair: Court Pedersen, MD Odense University Hospital
More Information

Responsible Party: Court Pedersen / professor, Department of Infectious Diseases, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00952861     History of Changes
Other Study ID Numbers: OUH-INF-1
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: June 2010

Keywords provided by Odense University Hospital:
Chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents