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CHRONIC OBSTRUCTIVE PULMONARY DISEASE |
1 Department of Medicine, Queen Elizabeth Hospital, Birmingham B15 2HT, UK
2 Department of Respiratory Medicine, GSK R&D, Greenford, Middlesex UB6 0HE, UK
Correspondence to:
Correspondence to:
Professor Robert Stockley
Department of Medicine, Queen Elizabeth Hospital, Birmingham B15 2HT, UK; r.a.stockley{at}bham.ac.uk
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 (
10% predicted forced expiratory volume in 1 second) received either salmeterol 50 µg 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).
Conclusion: 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.
Abbreviations: COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; IC, inspiratory capacity; ICS, inhaled corticosteroid; ITT, intent-to-treat; LABA, long acting ß agonist; MMEF, maximum mid-expiratory flow; PPP, per protocol population; SGRQ, St George’s Respiratory Questionnaire; SVC, slow vital capacity
Keywords: chronic obstructive pulmonary disease; exacerbations; inspiratory capacity; salmeterol
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