Addition of salmeterol to existing treatment in patients with COPD: a 12 month study.
BACKGROUND
This study investigated the addition of salmeterol to existing treatment for exacerbations in patients with poorly reversible chronic obstructive pulmonary disease (COPD).


METHODS
634 patients aged >40 years with a history of COPD exacerbations (including at least two in the previous year) and poor reversibility of airflow obstruction (< or =10% predicted forced expiratory volume in 1 second) received either salmeterol 50 mug or placebo twice daily from a Diskus inhaler for 12 months. The primary outcome was the number of moderate and severe exacerbations.


RESULTS
The median rate of moderate or severe exacerbations in the intent-to-treat (ITT) population was lower in the salmeterol group (0.00, range 0.0-9.8, n = 316) than in the placebo group (0.93, range 0.0-13.0, n = 318), but the difference was not statistically significant (p = 0.27). The median rate of exacerbations in the per protocol population (>90% compliance) was also found to be lower in the salmeterol group (0.00, range 0.0-5.0, n = 206) than in the placebo group (0.93, range 0.0-5.6, n = 195) and did reach statistical significance (p = 0.007). For secondary end points, patients receiving salmeterol had significant improvement in lung hyperinflation measured by inspiratory capacity which was evident at 4 weeks and maintained over 12 months (p = 0.035), and a significant improvement in health status measured by the St George's Respiratory Questionnaire at 12 months (p = 0.002).


CONCLUSIONS
Salmeterol has a positive effect on symptoms and health status of patients with COPD when added to usual treatment. Exacerbations are only reduced in patients who comply with treatment.
Stockley
R A
RA
Department of Medicine, Queen Elizabeth Hospital, Birmingham B15 2HT, UK. r.a.stockley@bham.ac.uk
Chopra
N
N
Rice
L
L
D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004417:Dyspnea / Q000209:etiology; D017079:Exercise Tolerance; D005260:Female; D005541:Forced Expiratory Volume / Q000502:physiology; D006304:Health Status; D006801:Humans; D008176:Lung Volume Measurements; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D000068299:Salmeterol Xinafoate; D014797:Vital Capacity / Q000502:physiology
D001993:Bronchodilator Agents; D000068299:Salmeterol Xinafoate; D000420:Albuterol