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Obstructive Lung Diseases |

The Tiotropium Safety and Performance in Respimat (TIOSPIR) trial: Bronchodilator efficacy in a spirometry substudy

Antonio Anzueto, MD; Robert Wise, MD; Gordon Pledger, PhD; Peter Calverley, MD; Daniel Dusser, MD; Daniel Cotton, MS; Theresa Devins, DrPH; Bernd Disse, MD; Elizabeth Joseph, MPH; Sabine Kattenbeck, MD; Michael Koenen-Bergmann, MD; Ronald Dahl, MD
Author and Funding Information

Pulmonary Critical Care Center, San Antonio, TX


Chest. 2013;144(4_MeetingAbstracts):1027A. doi:10.1378/chest.1783312
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Abstract

SESSION TITLE: COPD

SESSION TYPE: Original Investigation Slide

PRESENTED ON: Wednesday, October 30, 2013 at 02:45 PM - 03:45 PM

PURPOSE: The TIOSPIR trial was designed to compare directly the safety and efficacy of tiotropium Respimat® with tiotropium HandiHaler® in COPD. A spirometry substudy compared the bronchodilator efficacy for up to 120 weeks.

METHODS: TIOSPIR was a large-scale, long-term, randomized, double-blind, double dummy, parallel-group trial of 17,135 participants with COPD (age ≥40 years; post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] ratio ≤0.70; FEV1 ≤70% predicted). A total of 1370 participants were randomized in the substudy to receive once-daily tiotropium Respimat 5 µg (n=461) or 2.5 µg (n=464) or tiotropium HandiHaler 18 µg (n=445). Trough FEV1 and FVC were measured at baseline and every 24 weeks. Pre-defined tests were non-inferiority of tiotropium Respimat 5 µg and 2.5 µg compared to tiotropium HandiHaler 18 µg for trough FEV1 (average 24 to 120 weeks), with a non-inferiority margin of 50 mL.

RESULTS: Adjusted mean trough FEV1 was 1.285 L for participants treated with tiotropium Respimat 5 µg and 1.295 L for tiotropium HandiHaler 18 µg (difference vs HandiHaler, -10 mL; 95% CI, -38 to 18 mL). Adjusted mean trough FEV1 was 1.258 L for tiotropium Respimat 2.5 µg (difference vs HandiHaler, -37 mL; 95% CI, -65 to -9 mL). Non-inferiority to tiotropium HandiHaler 18 µg was therefore achieved for tiotropium Respimat 5 µg but failed for tiotropium Respimat 2.5 µg.

CONCLUSIONS: Tiotropium Respimat 5 µg was non-inferior to tiotropium HandiHaler 18 µg for FEV1 (average 24 to 120 weeks), but Respimat 2.5 µg was not.

CLINICAL IMPLICATIONS: Tiotropium Respimat 5 µg provides similar bronchodilator efficacy to tiotropium HandiHaler 18 µg.

DISCLOSURE: Antonio Anzueto: Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Forest Labs, Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline, Consultant fee, speaker bureau, advisory committee, etc.: Novartis Robert Wise: Other: Boehringer Ingelheim Gordon Pledger: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim Peter Calverley: Consultant fee, speaker bureau, advisory committee, etc.: Novartis, Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Takeda Daniel Dusser: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Pfizer, Consultant fee, speaker bureau, advisory committee, etc.: Novartis, Consultant fee, speaker bureau, advisory committee, etc.: Chiesi, Consultant fee, speaker bureau, advisory committee, etc.: Nycomed, Consultant fee, speaker bureau, advisory committee, etc.: Dey Pharma LP Daniel Cotton: Employee: Boehringer Ingelheim Theresa Devins: Employee: Boehringer Ingelheim Bernd Disse: Employee: Boehringer Ingelheim Elizabeth Joseph: Employee: Boehringer Ingelheim Sabine Kattenbeck: Employee: Boehringer Ingelheim Michael Koenen-Bergmann: Employee: Boehringer Ingelheim Ronald Dahl: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Novartis

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