The effect of oral clarithromycin on health status and sputum bacteriology in stable COPD.
BACKGROUND
Chronic obstructive pulmonary disease (COPD) is characterised by airway inflammation, poor health status and recurrent infective exacerbations. Macrolide antibiotics have been shown to improve symptoms and exacerbation rate in chronic lung disease, particularly cystic fibrosis (CF) and diffuse pan-bronchiolitis. The effect of long-term oral clarithromycin on health status, sputum bacterial numbers and exacerbation rate in subjects with clinically stable COPD is undetermined.


METHODS
Subjects with moderate-to-severe COPD were recruited into a prospective, double-blind, randomised-controlled trial of 3-months oral clarithromycin (Klaricid XL) or placebo once-daily. The effect of clarithromycin on health status (St. George respiratory and Short Form-36 questionnaires), sputum quantitative bacterial numbers and exacerbation rate were investigated.


RESULTS
Sixty-seven subjects (46 males) were recruited; 31 and 36 subjects received clarithromycin and placebo, respectively. There were 7(10%) withdrawals. Compared to placebo, clarithromycin did not significantly improve health status, sputum bacterial numbers, or exacerbation rate.


CONCLUSIONS
Three months of oral clarithromycin given to subjects with stable COPD does not improve health status, sputum bacterial numbers or exacerbation rate. Treatment of COPD with clarithromycin during the clinical stable state yields no clinical advantages and therefore cannot be recommended as means of eliminating sputum bacteria or preventing infective exacerbations.
Banerjee
D
D
Department of Respiratory Medicine, City Hospital, Birmingham, UK.
Khair
O A
OA
Honeybourne
D
D
D000284:Administration, Oral; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D017291:Clarithromycin / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006304:Health Status; D006801:Humans; D008297:Male; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000382:microbiology; D011788:Quality of Life; D012907:Smoking; D013183:Sputum / Q000382:microbiology; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects
D000900:Anti-Bacterial Agents; D017291:Clarithromycin