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10.1186/s12931-015-0269-4

http://scihub22266oqcxt.onion/10.1186/s12931-015-0269-4
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suck abstract from ncbi


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pmid26369563      Respir+Res 2015 ; 16 (1): ä
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  • The Tiotropium Safety and Performance in RespimatŪ (TIOSPIRŪ) Trial: Spirometry Outcomes #MMPMID26369563
  • Anzueto A; Wise R; Calverley P; Dusser D; Tang W; Metzdorf N; Dahl R
  • Respir Res 2015[]; 16 (1): ä PMID26369563show ga
  • Background: Tiotropium Safety and Performance in RespimatŪ (TIOSPIRŪ) compared the safety and efficacy of tiotropium RespimatŪ and tiotropium HandiHalerŪ in patients with chronic obstructive pulmonary disease (COPD). A prespecified spirometry substudy compared the lung function efficacy between treatment groups. Methods: TIOSPIRŪ was a large-scale, long-term (2.3-year), event-driven, randomized, double-blind, parallel-group trial of 17,135 patients with COPD. In the spirometry substudy, trough forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) were measured at baseline and every 24 weeks for the duration of the trial. Results: The substudy included 1370 patients who received once-daily tiotropium RespimatŪ 5 ?g (n?=?461), 2.5 ?g (n?=?464), or tiotropium HandiHalerŪ 18 ?g (n?=?445). Adjusted mean trough FEV1 (average 24?120 weeks) was 1.285, 1.258, and 1.295 L in the RespimatŪ 5 ?g, 2.5 ?g, and HandiHalerŪ 18 ?g groups (difference versus HandiHalerŪ [95 % CI]: ?10 [?38, 18] mL for RespimatŪ 5 ?g and, ?37 [?65, ?9] mL for RespimatŪ 2.5 ?g); achieving noninferiority to tiotropium HandiHalerŪ 18 ?g for tiotropium RespimatŪ 5 but not for 2.5 ?g (prespecified analysis). Adjusted mean trough FVC was 2.590, 2.544, and 2.593 L in the RespimatŪ 5 ?g, 2.5 ?g, and HandiHalerŪ 18 ?g groups. The rates of FEV1 decline over 24 to 120 weeks were similar for the three treatment arms (26, 40, and 34 mL/year for the tiotropium RespimatŪ 5-?g, 2.5-?g, and HandiHalerŪ 18-?g groups). The rate of FEV1 decline in GOLD I?+?II patients was greater than in GOLD III?+?IV patients (46 vs. 23 mL/year); as well as in current versus ex-smokers, in patients receiving combination therapies at baseline versus not, and in those experiencing an exacerbation during the study versus not. Conclusions: The TIOSPIRŪ spirometry substudy showed that tiotropium RespimatŪ 5 ?g was noninferior to tiotropium HandiHalerŪ 18 ?g for trough FEV1, but RespimatŪ 2.5 ?g was not. Tiotropium RespimatŪ 5 ?g provides similar bronchodilator efficacy to tiotropium HandiHalerŪ 18 ?g with comparable rates of FEV1 decline. The rate of FEV1 decline varied based on disease severity, with a steeper rate of decline observed in patients with moderate airway obstruction. Trial registration: NCT01126437. Electronic supplementary material: The online version of this article (doi:10.1186/s12931-015-0269-4) contains supplementary material, which is available to authorized users.
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