Tiotropium + olodaterol shows clinically meaningful improvements in quality of life.
Respir Med
; 109(10): 1312-9, 2015 Oct.
Article
em En
| MEDLINE
| ID: mdl-26320402
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Antagonistas Muscarínicos
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Doença Pulmonar Obstrutiva Crônica
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Benzoxazinas
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Agonistas de Receptores Adrenérgicos beta 2
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Brometo de Tiotrópio
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article