PubMed:26369563 JSONTXT

{"project":"Linmchun_800_3","denotations":[{"id":"T1","span":{"begin":4,"end":14},"obj":"CI"},{"id":"T10","span":{"begin":1952,"end":1962},"obj":"CI"},{"id":"T11","span":{"begin":1997,"end":2007},"obj":"CI"},{"id":"T12","span":{"begin":2073,"end":2083},"obj":"CI"},{"id":"T13","span":{"begin":2143,"end":2153},"obj":"CI"},{"id":"T14","span":{"begin":548,"end":552},"obj":"DP"},{"id":"T15","span":{"begin":300,"end":304},"obj":"DP"},{"id":"T16","span":{"begin":261,"end":298},"obj":"DP"},{"id":"T17","span":{"begin":52,"end":60},"obj":"CI"},{"id":"T18","span":{"begin":150,"end":158},"obj":"CI"},{"id":"T19","span":{"begin":413,"end":421},"obj":"CI"},{"id":"T2","span":{"begin":102,"end":112},"obj":"CI"},{"id":"T20","span":{"begin":1911,"end":1919},"obj":"CI"},{"id":"T21","span":{"begin":1574,"end":1585},"obj":"CI"},{"id":"T22","span":{"begin":2008,"end":2019},"obj":"CI"},{"id":"T23","span":{"begin":2154,"end":2165},"obj":"CI"},{"id":"T24","span":{"begin":1209,"end":1220},"obj":"CI"},{"id":"T25","span":{"begin":1388,"end":1399},"obj":"CI"},{"id":"T26","span":{"begin":1066,"end":1077},"obj":"CI"},{"id":"T27","span":{"begin":1022,"end":1033},"obj":"CI"},{"id":"T28","span":{"begin":232,"end":243},"obj":"CI"},{"id":"T29","span":{"begin":879,"end":890},"obj":"CI"},{"id":"T3","span":{"begin":196,"end":206},"obj":"CI"},{"id":"T30","span":{"begin":821,"end":830},"obj":"CI"},{"id":"T31","span":{"begin":994,"end":1003},"obj":"CI"},{"id":"T32","span":{"begin":1110,"end":1119},"obj":"CI"},{"id":"T33","span":{"begin":1151,"end":1160},"obj":"CI"},{"id":"T34","span":{"begin":1242,"end":1251},"obj":"CI"},{"id":"T35","span":{"begin":1360,"end":1369},"obj":"CI"},{"id":"T36","span":{"begin":41,"end":50},"obj":"CI"},{"id":"T37","span":{"begin":139,"end":148},"obj":"CI"},{"id":"T38","span":{"begin":207,"end":216},"obj":"CI"},{"id":"T39","span":{"begin":1963,"end":1972},"obj":"CI"},{"id":"T4","span":{"begin":221,"end":231},"obj":"CI"},{"id":"T40","span":{"begin":2047,"end":2056},"obj":"CI"},{"id":"T41","span":{"begin":2084,"end":2093},"obj":"CI"},{"id":"T5","span":{"begin":810,"end":820},"obj":"CI"},{"id":"T6","span":{"begin":868,"end":878},"obj":"CI"},{"id":"T7","span":{"begin":1198,"end":1208},"obj":"CI"},{"id":"T8","span":{"begin":1231,"end":1241},"obj":"CI"},{"id":"T9","span":{"begin":1535,"end":1545},"obj":"CI"},{"id":"T42","span":{"begin":1546,"end":1555},"obj":"CI"}],"text":"The Tiotropium Safety and Performance in Respimat® (TIOSPIR®) Trial: Spirometry Outcomes.\nBACKGROUND: Tiotropium Safety and Performance in Respimat® (TIOSPIR®) compared the safety and efficacy of tiotropium Respimat® and tiotropium HandiHaler® in patients with chronic obstructive pulmonary disease (COPD). A prespecified spirometry substudy compared the lung function efficacy between treatment groups.\nMETHODS: TIOSPIR® 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.\nRESULTS: The substudy included 1370 patients who received once-daily tiotropium Respimat® 5 μg (n = 461), 2.5 μg (n = 464), or tiotropium HandiHaler® 18 μg (n = 445). Adjusted mean trough FEV1 (average 24-120 weeks) was 1.285, 1.258, and 1.295 L in the Respimat® 5 μg, 2.5 μg, and HandiHaler® 18 μg groups (difference versus HandiHaler® [95 % CI]: -10 [-38, 18] mL for Respimat® 5 μg and, -37 [-65, -9] mL for Respimat® 2.5 μg); achieving noninferiority to tiotropium HandiHaler® 18 μg for tiotropium Respimat® 5 but not for 2.5 μg (prespecified analysis). Adjusted mean trough FVC was 2.590, 2.544, and 2.593 L in the Respimat® 5 μg, 2.5 μg, and HandiHaler® 18 μg 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 Respimat® 5-μg, 2.5-μg, and HandiHaler® 18-μg 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.\nCONCLUSIONS: The TIOSPIR® spirometry substudy showed that tiotropium Respimat® 5 μg was noninferior to tiotropium HandiHaler® 18 μg for trough FEV1, but Respimat® 2.5 μg was not. Tiotropium Respimat® 5 μg provides similar bronchodilator efficacy to tiotropium HandiHaler® 18 μg 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.\nTRIAL REGISTRATION: NCT01126437."}

{"project":"luoyt2021_800_3","denotations":[{"id":"T1","span":{"begin":41,"end":50},"obj":"CI"},{"id":"T10","span":{"begin":994,"end":1003},"obj":"CI"},{"id":"T11","span":{"begin":821,"end":830},"obj":"CI"},{"id":"T12","span":{"begin":207,"end":216},"obj":"CI"},{"id":"T13","span":{"begin":139,"end":148},"obj":"CI"},{"id":"T14","span":{"begin":52,"end":60},"obj":"CI"},{"id":"T15","span":{"begin":150,"end":158},"obj":"CI"},{"id":"T16","span":{"begin":2154,"end":2165},"obj":"CI"},{"id":"T17","span":{"begin":2143,"end":2153},"obj":"CI"},{"id":"T18","span":{"begin":2008,"end":2019},"obj":"CI"},{"id":"T19","span":{"begin":1997,"end":2007},"obj":"CI"},{"id":"T2","span":{"begin":2084,"end":2093},"obj":"CI"},{"id":"T20","span":{"begin":2073,"end":2083},"obj":"CI"},{"id":"T21","span":{"begin":1952,"end":1962},"obj":"CI"},{"id":"T22","span":{"begin":1911,"end":1919},"obj":"CI"},{"id":"T23","span":{"begin":1231,"end":1241},"obj":"CI"},{"id":"T24","span":{"begin":1209,"end":1220},"obj":"CI"},{"id":"T25","span":{"begin":1198,"end":1208},"obj":"CI"},{"id":"T26","span":{"begin":810,"end":820},"obj":"CI"},{"id":"T27","span":{"begin":4,"end":14},"obj":"CI"},{"id":"T28","span":{"begin":102,"end":112},"obj":"CI"},{"id":"T29","span":{"begin":196,"end":206},"obj":"CI"},{"id":"T3","span":{"begin":2047,"end":2056},"obj":"CI"},{"id":"T30","span":{"begin":221,"end":231},"obj":"CI"},{"id":"T31","span":{"begin":232,"end":243},"obj":"CI"},{"id":"T32","span":{"begin":413,"end":421},"obj":"CI"},{"id":"T33","span":{"begin":1535,"end":1545},"obj":"CI"},{"id":"T34","span":{"begin":868,"end":878},"obj":"CI"},{"id":"T35","span":{"begin":261,"end":298},"obj":"DP"},{"id":"T36","span":{"begin":300,"end":304},"obj":"DP"},{"id":"T37","span":{"begin":548,"end":552},"obj":"DP"},{"id":"T4","span":{"begin":1963,"end":1972},"obj":"CI"},{"id":"T5","span":{"begin":1546,"end":1555},"obj":"CI"},{"id":"T6","span":{"begin":1360,"end":1369},"obj":"CI"},{"id":"T7","span":{"begin":1242,"end":1251},"obj":"CI"},{"id":"T8","span":{"begin":1151,"end":1160},"obj":"CI"},{"id":"T9","span":{"begin":1110,"end":1119},"obj":"CI"},{"id":"T38","span":{"begin":1574,"end":1585},"obj":"CI"},{"id":"T39","span":{"begin":1388,"end":1399},"obj":"CI"},{"id":"T40","span":{"begin":1066,"end":1077},"obj":"CI"},{"id":"T41","span":{"begin":1022,"end":1033},"obj":"CI"},{"id":"T42","span":{"begin":879,"end":890},"obj":"CI"}],"text":"The Tiotropium Safety and Performance in Respimat® (TIOSPIR®) Trial: Spirometry Outcomes.\nBACKGROUND: Tiotropium Safety and Performance in Respimat® (TIOSPIR®) compared the safety and efficacy of tiotropium Respimat® and tiotropium HandiHaler® in patients with chronic obstructive pulmonary disease (COPD). A prespecified spirometry substudy compared the lung function efficacy between treatment groups.\nMETHODS: TIOSPIR® 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.\nRESULTS: The substudy included 1370 patients who received once-daily tiotropium Respimat® 5 μg (n = 461), 2.5 μg (n = 464), or tiotropium HandiHaler® 18 μg (n = 445). Adjusted mean trough FEV1 (average 24-120 weeks) was 1.285, 1.258, and 1.295 L in the Respimat® 5 μg, 2.5 μg, and HandiHaler® 18 μg groups (difference versus HandiHaler® [95 % CI]: -10 [-38, 18] mL for Respimat® 5 μg and, -37 [-65, -9] mL for Respimat® 2.5 μg); achieving noninferiority to tiotropium HandiHaler® 18 μg for tiotropium Respimat® 5 but not for 2.5 μg (prespecified analysis). Adjusted mean trough FVC was 2.590, 2.544, and 2.593 L in the Respimat® 5 μg, 2.5 μg, and HandiHaler® 18 μg 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 Respimat® 5-μg, 2.5-μg, and HandiHaler® 18-μg 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.\nCONCLUSIONS: The TIOSPIR® spirometry substudy showed that tiotropium Respimat® 5 μg was noninferior to tiotropium HandiHaler® 18 μg for trough FEV1, but Respimat® 2.5 μg was not. Tiotropium Respimat® 5 μg provides similar bronchodilator efficacy to tiotropium HandiHaler® 18 μg 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.\nTRIAL REGISTRATION: NCT01126437."}