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

Odense University Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo (matching); Drug: Doxycycline

Study type: Interventional

Funder types: Other

Identifiers

NCT00952861

OUH-INF-1

Details and patient eligibility

About

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

Enrollment: 140 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Doxycycline

Active Comparator group

Description:

Doxycycline 200 mg QD in 5 days

Treatment:

Drug: Doxycycline

Placebo

Placebo Comparator group

Description:

Matching placebo QD i 5 days

Treatment:

Drug: Placebo (matching)