Antibiotics in Chronic Obstructive Pulmonary Disease (COPD) (TAExaCOP)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Withdrawn
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Doxycycline
Placebo (matching)
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic obstructive pulmonary disease, Infection, Antibiotics
Eligibility Criteria
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
Sites / Locations
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Doxycycline
Placebo
Arm Description
Doxycycline 200 mg QD in 5 days
Matching placebo QD i 5 days
Outcomes
Primary Outcome Measures
6 minutes walking distance
Secondary Outcome Measures
Time to next episode of acute exacerbation
Full Information
NCT ID
NCT00952861
First Posted
July 24, 2009
Last Updated
August 10, 2010
Sponsor
Odense University Hospital
Collaborators
Kolding Sygehus, Svendborg Hospital, Fredericia Hospital, Naestved Hospital, Hillerod Hospital, Denmark, Region Syddanmark, Danmarks Lungeforening, Danish National Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00952861
Brief Title
Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
TAExaCOP
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 Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Stopped due to poor recruitment
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
Collaborators
Kolding Sygehus, Svendborg Hospital, Fredericia Hospital, Naestved Hospital, Hillerod Hospital, Denmark, Region Syddanmark, Danmarks Lungeforening, Danish National Research Foundation
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Chronic obstructive pulmonary disease, Infection, Antibiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Doxycycline
Arm Type
Active Comparator
Arm Description
Doxycycline 200 mg QD in 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo QD i 5 days
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
200 mg QD in 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo (matching)
Intervention Description
Placebo QD i 5 days
Primary Outcome Measure Information:
Title
6 minutes walking distance
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Time to next episode of acute exacerbation
Time Frame
Days 14, 30, 90 and 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Court Pedersen, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
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Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)
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