To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.
COPD is characterized by progressive development of airflow limitation that is poorly reversible. Because of a poor understanding of COPD pathogenesis, treatment is mostly symptomatic and new therapeutic strategies are limited. There is a direct relationship between the severity of the disease and the intensity of the inflammatory response.One of the hypothesis for persistent airway inflammation is that the presence of recurrent infections is responsible for this condition. Macrolide antibiotics have a bacteriostatic as well as anti-inflammatory properties. This clinical trial will investigate whether maintenance treatment with macrolide antibiotics during 1 year in people with 3 or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in that same year of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
92
Subjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin during 1 year.
Persons in this group will receive 3 times a week placebo of azithromycin during 1 year.
Amphia Ziekenhuis
Breda, North Brabant, Netherlands
Reduction in number of exacerbations
Time frame: 1 year
Lung function parameters (FEV1 (L), FVC (L), FRC (L), RV (L), TLC(L), IC (L), 6 minute walking distance)
Time frame: Day 1. Also 3, 6, 9 and 12 months.
Disease specific health related quality of life measured by St. George's Respiratory Questionnaire (SGRQ)
Time frame: Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation.
Indication of anxiety and depression by Hospital Anxiety Depression Scale (HADS)
Time frame: Day 1. Also 3, 6, 9 and 12 months.
Microbiology of sputum (culture and PCR).
Time frame: Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation of COPD.
Measurement of inflammatory markers in sputum and serum.
Time frame: Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation of COPD.
Adverse events of treatment.
Time frame: Day 1. Also 3, 6, 9 and 12 months. Whenever adverse events occur.
Length of hospital stay.
Time frame: Whenever admission to hospital is required for an exacerbation of COPD.
Time till next exacerbation.
Time frame: Whenever an exacerbation of COPD occurs.
Assess type D personality by DS-14 questionnaire.
Time frame: Day 1 and month 12.
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Generic health status measured by 12-Item Short Form Health Survey (SF-12).
Time frame: Day 1, month 3, 6, 9 and 12. In case of an exacerbation.
Decrease in percentage of clinical versus outdoor department exacerbations.
Time frame: Month 12.
Effect of maintenance macrolides on intestinal bacterial restistancy patterns
Time frame: Day 1, month 6 and month 12
Serology and PCR for atypical microorganisms in serum
Time frame: day 1. In case of an exacerbation.
Intestinal bacterial resistance patterns
Rectal swabs will be tested for bacterial resistance patterns and change in rectal flora as a result of maintenance azithromycin.
Time frame: Day 1, month 6 and month 12