Addition of salmeterol to existing treatment in patients with COPD: a 12 month study
- 1Department of Medicine, Queen Elizabeth Hospital, Birmingham B15 2HT, UK
- 2Department of Respiratory Medicine, GSK R&D, Greenford, Middlesex UB6 0HE, UK
- Correspondence to:
Professor Robert Stockley
Department of Medicine, Queen Elizabeth Hospital, Birmingham B15 2HT, UK;
- Received 13 October 2004
- Accepted 21 October 2005
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.
- 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 β agonist
- MMEF, maximum mid-expiratory flow
- PPP, per protocol population
- SGRQ, St George’s Respiratory Questionnaire
- SVC, slow vital capacity
This manuscript was prepared on behalf of an international study group from 19 countries: G Kaik, N Vetter (Austria); D Popov, D Osmanliev, K Kissiova, P Mandulova, J J Ivanov (Bulgaria); J B Martinot, D Rozen, R Louis, R Pauwels, I J M Stappaerts (Belgium); N Tudoric, F Pavicic, Z Beg Zec, S Skrinjaric Cincar, I Gudelj (Croatia); J Musil, J Krepelka, A Matulova, R Kasak (Czech Republic); J Korsgaard, F F Madsen, H Harving, J I Jensen, P Garsdal (Denmark); S Lane, T McDonnell (Ireland); T Kipper, L Raudla (Estonia); P Hyvernat, M Legendre, P Zuck, S Beaujot, J P Moreau, E Fournier, P Godard, T Similowski, F Ruff, G Pecastaing, N Roche, B Lebrozec, J Y Jasnot (France); H ten Hoff, A Benedix, J Eller, E Liefring, U Westerhausen, W Zachgo, J Bargon, W Westphal (Germany); H Berendsen, H Sinninghe Damste (Holland); I Herjavecz, K Radich, E Juhász, Z Márk, M Jedlinszki, I Áchim (Hungary); V Silins, J Krams (Latvia); W Droszcz, A Szczeklik, M Slominski, J Kruszewski (Poland); J Sanchís, M Rosales Jaldo, S Bardagi, C Esteban, J Serra, JM Rodriguez (Spain); E Rozborilova, P Kristufek, J Mazal, J Simovicova (Slovak Republic); J Sorli, R Kopriva, S Kajba (Slovenia); Y Yashyna, Y Feschenko (Ukraine); G Basran, P M A Calverley, M Wilkins, B Higgins (UK).
Funding for the study was provided by Glaxo Wellcome Research and Development (protocol SMS40026).
Competing interests: none declared.