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Respir Med. 2015 Oct;109(10):1312-9. doi: 10.1016/j.rmed.2015.08.002. Epub 2015 Aug 12.

Tiotropium + olodaterol shows clinically meaningful improvements in quality of life.

Author information

1
The Medicines Evaluation Unit, Manchester, UK. Electronic address: dsingh@meu.org.uk.
2
Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA.
3
Krankenhaus der Elisabethinen, Linz, Austria.
4
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
5
Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
6
Morgantown Pulmonary Associates, Morgantown, WV, USA.
7
Lungen- und Bronchialheilkunde, Koblenz, Germany.
8
Department of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.

Abstract

BACKGROUND:

Tiotropium + olodaterol improves lung function and symptoms compared to monotherapies in chronic obstructive pulmonary disease (COPD). The OTEMTO 1 and 2 studies investigated the effects of tiotropium + olodaterol on lung function and health-related quality of life compared to placebo in patients with moderate to severe COPD.

METHODS:

In these two replicate, double-blind, parallel-group, placebo-controlled trials, patients were randomised to receive tiotropium + olodaterol 5/5 μg, 2.5/5 μg, tiotropium 5 μg or placebo for 12 weeks, via the Respimat(®) inhaler. Primary end points were St George's Respiratory Questionnaire (SGRQ) total score, forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0-3) response and trough FEV1 response.

RESULTS:

In OTEMTO 1 and 2, tiotropium + olodaterol 5/5 μg improved SGRQ total score by 4.89 (95% confidence interval [CI] -6.90, -2.88) and 4.56 (95% CI -6.50, -2.63) units versus placebo (both p < 0.0001), and 2.49 (95% CI -4.47, -0.51; p < 0.05) and 1.72 (95% CI -3.63, 0.19) units versus tiotropium 5 μg. Tiotropium + olodaterol 2.5/5 μg significantly improved SGRQ score compared to placebo. Both doses significantly improved FEV1 AUC0-3 response compared to placebo and tiotropium 5 μg. Tiotropium + olodaterol 5/5 and 2.5/5 μg also significantly improved trough FEV1 response compared to placebo (both studies) and separated from tiotropium 5 μg in OTEMTO 2. Adverse-event incidence was similar between treatment groups.

CONCLUSION:

Tiotropium + olodaterol improved lung function and quality of life compared to placebo and tiotropium 5 μg.

TRIAL REGISTRATION:

ClinicalTrials.gov: NCT01964352 and NCT02006732.

KEYWORDS:

COPD; Long-acting bronchodilator; Olodaterol; Quality of life; Tiotropium

PMID:
26320402
DOI:
10.1016/j.rmed.2015.08.002
[Indexed for MEDLINE]
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