Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease (COLUMBUS)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Influence of Macrolide Maintenance Therapy and Bacterial Colonisation on Exacerbation Frequency and Progression of COPD, a Randomized Double-blind Placebo-controlled Trial|
- 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. ]
- 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 [ Time Frame: Day 1, month 6 and month 12 ]Rectal swabs will be tested for bacterial resistance patterns and change in rectal flora as a result of maintenance azithromycin.
|Study Start Date:||May 2010|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Azithromycin
Subjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin
Subjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin during 1 year.
Placebo Comparator: Placebo
Subjects in this group will receive 3 times a week placebo
Persons in this group will receive 3 times a week placebo of azithromycin during 1 year.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985244
|Breda, Noord-Brabant, Netherlands, 4818 CK|
|Study Director:||Joachim Aerts, MD, PhD||Amphia Ziekenhuis|
|Study Director:||Menno van der Eerdem, MD, PhD||Erasmus MC|