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The Tiotropium Safety and Performance in Respimat® (TIOSPIR®) Trial: Spirometry Outcomes.
Respir Res. 2015 Sep 15; 16:107.RR

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

TRIAL REGISTRATION

NCT01126437.

Authors+Show Affiliations

Pulmonary/Critical Care, University of Texas Health Science Center, and South Texas Veterans Health Care System, 111E, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA. anzueto@uthscsa.edu.Johns Hopkins University School of Medicine, Baltimore, MD, USA. rwise@jhmi.edu.Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK. pmacal@liverpool.ac.uk.Service de Pneumologie Hôpital Cochin, Paris, France. daniel.dusser@cch.aphp.fr.Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA. wenbo.tang@boehringer-ingelheim.com.Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany. norbert.metzdorf@boehringer-ingelheim.com.Odense University Hospital, Odense, Denmark. ronald.dahl2@rsyd.dk.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26369563

Citation

Anzueto, Antonio, et al. "The Tiotropium Safety and Performance in Respimat® (TIOSPIR®) Trial: Spirometry Outcomes." Respiratory Research, vol. 16, 2015, p. 107.
Anzueto A, Wise R, Calverley P, et al. The Tiotropium Safety and Performance in Respimat® (TIOSPIR®) Trial: Spirometry Outcomes. Respir Res. 2015;16:107.
Anzueto, A., Wise, R., Calverley, P., Dusser, D., Tang, W., Metzdorf, N., & Dahl, R. (2015). The Tiotropium Safety and Performance in Respimat® (TIOSPIR®) Trial: Spirometry Outcomes. Respiratory Research, 16, 107. https://doi.org/10.1186/s12931-015-0269-4
Anzueto A, et al. The Tiotropium Safety and Performance in Respimat® (TIOSPIR®) Trial: Spirometry Outcomes. Respir Res. 2015 Sep 15;16:107. PubMed PMID: 26369563.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Tiotropium Safety and Performance in Respimat® (TIOSPIR®) Trial: Spirometry Outcomes. AU - Anzueto,Antonio, AU - Wise,Robert, AU - Calverley,Peter, AU - Dusser,Daniel, AU - Tang,Wenbo, AU - Metzdorf,Norbert, AU - Dahl,Ronald, Y1 - 2015/09/15/ PY - 2015/05/11/received PY - 2015/08/26/accepted PY - 2015/9/16/entrez PY - 2015/9/16/pubmed PY - 2016/7/12/medline SP - 107 EP - 107 JF - Respiratory research JO - Respir. Res. VL - 16 N2 - BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: NCT01126437. SN - 1465-993X UR - https://www.unboundmedicine.com/medline/citation/26369563/The_Tiotropium_Safety_and_Performance_in_Respimat®__TIOSPIR®__Trial:_Spirometry_Outcomes_ L2 - https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-015-0269-4 DB - PRIME DP - Unbound Medicine ER -