Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00952861

Last Updated: 2010-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Doxycycline

Doxycycline 200 mg QD in 5 days

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

200 mg QD in 5 days

Placebo

Matching placebo QD i 5 days

Group Type PLACEBO_COMPARATOR

Placebo (matching)

Intervention Type DRUG

Placebo QD i 5 days

Interventions

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Doxycycline

200 mg QD in 5 days

Intervention Type DRUG

Placebo (matching)

Placebo QD i 5 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kolding Sygehus

OTHER

Sponsor Role collaborator

Svendborg Hospital

OTHER

Sponsor Role collaborator

Fredericia Hospital

UNKNOWN

Sponsor Role collaborator

Naestved Hospital

OTHER

Sponsor Role collaborator

Hillerod Hospital, Denmark

OTHER

Sponsor Role collaborator

Region Syddanmark

OTHER

Sponsor Role collaborator

Danmarks Lungeforening

OTHER

Sponsor Role collaborator

Danish National Research Foundation

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Infectious Diseases, Odense University Hospital

Principal Investigators

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Court Pedersen, MD

Role: STUDY_CHAIR

Odense University Hospital

Locations

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Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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OUH-INF-1

Identifier Type: -

Identifier Source: org_study_id

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