Bronchodilator Efficacy of Combined Salmeterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease

• Published in: Archivos de bronconeumología (English ed.) 2005-03, Vol.41 (3), p.130-134
• Main Authors: Baloira Villar, A., Vilariño Pombo, C.
• Format: Article
• Language: eng ; spa
• Subjects: Albuterol - administration & dosage; Albuterol - adverse effects; Albuterol - analogs & derivatives; Androstadienes - administration & dosage; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Chronic obstructive pulmonary disease (COPD); Cross-Over Studies; Data Interpretation, Statistical; Double-Blind Method; Drug Therapy, Combination; Enfermedad pulmonar obstructiva crónica (EPOC); Espirometría; Female; Fluticasone; Forced Expiratory Volume; Humans; Male; Middle Aged; Placebos; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Salmeterol; Salmeterol Xinafoate; Scopolamine Derivatives - administration & dosage; Scopolamine Derivatives - adverse effects; Spirometry; Time Factors; Tiotropio; Tiotropium; Tiotropium Bromide; Treatment Outcome
• ISSN: 1579-2129; 0300-2896; 1579-2129
• DOI: 10.1016/S1579-2129(06)60413-8

Bronchodilators are still the most effective drugs for controlling the symptoms of chronic obstructive pulmonary disease (COPD). Tiotropium bromide, a long-acting anticholinergic drug, has recently been added to the therapeutic arsenal for the disease. To date, there have been no studies combining 2 long-acting bronchodilators. The aim of the present trial was to determine whether the combination of salmeterol and tiotropium improved lung function in COPD patients more than either of them alone. Twenty-two patients (20 men) diagnosed with COPD, with a mean age of 64 years, were enrolled in this cross-over trial. Active smokers were excluded. Mean (SD) forced expiratory volume in 1 second (FEV 1) was 43% (14%) of predicted. All patients were experienced in the use of inhalers. The following 3 therapeutic combinations were randomly assigned to be administered for a 1-week period: a) fluticasone (500 μg/12 h), salmeterol (50 μg/12 h) and placebo; b) fluticasone, tiotropium (18 μg/24 h), and placebo; and c) fluticasone, salmeterol, and tiotropium. At the end of each period, forced spirometry was performed before inhalation of the therapeutic combination (between 8:30 AM and 9:30 AM) and 2 hours after inhalation. Throughout the week, morning peak flow rates measured immediately before inhalation were recorded, and there was a 48-hour wash-out period between each therapeutic combination. All the patients completed the protocol. There were no significant differences in preinhalation or postinhalation FEV 1 with salmeterol compared to tiotropium (preinhalation FEV 1, 1.17 [0.55] L compared to 1.19 [0.49] L; postinhalation FEV 1, 1.32 [0.65] L compared to 1.29 [0.61] L). In all cases postinhalation FEV 1 was significantly higher than preinhalation FEV 1. The combination of fluticasone, salmeterol, and tiotropium proved superior to the other 2 combinations with respect to both preinhalation FEV1 and postinhalation FEV 1 (preinhalation FEV 1, 1.32 [0.56] L, [ P