Summary The aim of this double-blind, double-dummy, crossover, randomised, pilot study was to explore the acute effects of adding salmeterol and tiotropium in patients with stable COPD. A total of 20 outpatients with stable COPD were enrolled. Single doses of 18-mg tiotropium, 50-mg salmeterol, and 18-mg tiotropiumþ50-mg salmeterol were given. Serial measurements of forced expiratory volume in 1 s (FEV1) were performed over 24 h. The mean maximum increases in FEV1 from pre-dosing value on each of the dosing days were 0.165 l (95% CI: 0.098–0.232) for tiotropium, 0.241 l (95% CI: 0.151–0.332) for salmeterol, and 0.290 l (95% CI: 0.228–0.353) for the combination and occurred 4 h after inhalation of tiotropium or salmeterol and 3 h after the combination. At 12 h, the mean increases in FEV1 from pre-dosing value were 0.071 l (95% CI: 0.001–0.141; P ¼ 0:047) for tiotropium, 0.069 l (95% CI: 0.018- 0.120; P ¼ 0:010) for salmeterol, and 0.108 l (95% CI: 0.047–0.170; P ¼ 0:001) for the tiotropiumþsalmeterol combination. Only the difference between salmeterol and tiotropiumþsalmeterol was statistically significant (P ¼ 0:009). At 24 h, the mean FEV1 value was still higher than the mean pre-dosing value for tiotropium (0.042 l; 95% CI: 0.012–0.097; P ¼ 0:119) and the tiotropiumþsalmeterol combination (0.051 l; 95% CI: 0.015–0.087; P ¼ 0:007), but not for salmeterol alone ( 0.013 l; 95% CI: 0.041–0.014; P ¼ 0:324). The FEV1 area under the curve (AUCs0 12 h) were 1.657 l (95% CI: 1.152–2.162) for tiotropium, 2.068 l (95% CI: 1.385–2.752) for salmeterol, and 2.541 l (95% CI: 1.954–3.129) for tiotropiumþsalmeterol. Only the difference between tiotropium and the tiotropiumþsalmeterol combination was statistically significant (P ¼ 0:01). The FEV1 AUCs0 24 h were 2.854 l (95% CI: 1.928–3.780) for tiotropium, 2.786 l (95% CI: 1.913–3.660) for salmeterol, and 3.640 l (95% CI: 2.674–4.605) for tiotropiumþsalmeterol. All differences between treatments were not statistically significant (P40:05). These results seem to indicate that the use of the tiotropiumþsalmeterol combination is more efficacious than the single agents alone, but the once-daily administration of the two drugs is inadvisable due to the broncholytic profile of salmeterol

The functional impact of adding salmeterol and tiotropium in patients with stable COPD / M. Cazzola, S. Centanni, P. Santus, M. Verga, M. Mondoni, F. Di Marco, M.G. Matera. - In: RESPIRATORY MEDICINE. - ISSN 0954-6111. - 98:12(2004), pp. 1214-1221. [10.1016/j.rmed.2004.05.003]

The functional impact of adding salmeterol and tiotropium in patients with stable COPD

S. Centanni
Secondo
;
P. Santus;M. Mondoni;F. Di Marco
Penultimo
;
2004

Abstract

Summary The aim of this double-blind, double-dummy, crossover, randomised, pilot study was to explore the acute effects of adding salmeterol and tiotropium in patients with stable COPD. A total of 20 outpatients with stable COPD were enrolled. Single doses of 18-mg tiotropium, 50-mg salmeterol, and 18-mg tiotropiumþ50-mg salmeterol were given. Serial measurements of forced expiratory volume in 1 s (FEV1) were performed over 24 h. The mean maximum increases in FEV1 from pre-dosing value on each of the dosing days were 0.165 l (95% CI: 0.098–0.232) for tiotropium, 0.241 l (95% CI: 0.151–0.332) for salmeterol, and 0.290 l (95% CI: 0.228–0.353) for the combination and occurred 4 h after inhalation of tiotropium or salmeterol and 3 h after the combination. At 12 h, the mean increases in FEV1 from pre-dosing value were 0.071 l (95% CI: 0.001–0.141; P ¼ 0:047) for tiotropium, 0.069 l (95% CI: 0.018- 0.120; P ¼ 0:010) for salmeterol, and 0.108 l (95% CI: 0.047–0.170; P ¼ 0:001) for the tiotropiumþsalmeterol combination. Only the difference between salmeterol and tiotropiumþsalmeterol was statistically significant (P ¼ 0:009). At 24 h, the mean FEV1 value was still higher than the mean pre-dosing value for tiotropium (0.042 l; 95% CI: 0.012–0.097; P ¼ 0:119) and the tiotropiumþsalmeterol combination (0.051 l; 95% CI: 0.015–0.087; P ¼ 0:007), but not for salmeterol alone ( 0.013 l; 95% CI: 0.041–0.014; P ¼ 0:324). The FEV1 area under the curve (AUCs0 12 h) were 1.657 l (95% CI: 1.152–2.162) for tiotropium, 2.068 l (95% CI: 1.385–2.752) for salmeterol, and 2.541 l (95% CI: 1.954–3.129) for tiotropiumþsalmeterol. Only the difference between tiotropium and the tiotropiumþsalmeterol combination was statistically significant (P ¼ 0:01). The FEV1 AUCs0 24 h were 2.854 l (95% CI: 1.928–3.780) for tiotropium, 2.786 l (95% CI: 1.913–3.660) for salmeterol, and 3.640 l (95% CI: 2.674–4.605) for tiotropiumþsalmeterol. All differences between treatments were not statistically significant (P40:05). These results seem to indicate that the use of the tiotropiumþsalmeterol combination is more efficacious than the single agents alone, but the once-daily administration of the two drugs is inadvisable due to the broncholytic profile of salmeterol
Salmeterol ; Tiotropium ; Combination therapy ; COPD
Settore MED/10 - Malattie dell'Apparato Respiratorio
2004
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/145241
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