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The efficacy and safety of combined tiotropium and olodaterol via the Respimat(®) inhaler in patients with COPD: results from the Japanese sub-population of the Tonado(®) studies.
Int J Chron Obstruct Pulmon Dis. 2016; 11:2017-27.IJ

Abstract

BACKGROUND

The efficacy and safety of once-daily tiotropium + olodaterol (T+O) maintenance treatment was demonstrated in the large, multinational, replicate, randomized, Phase III, Tonado(®) 1 (NCT01431274) and 2 (NCT01431287) studies in patients with moderate to very severe COPD. However, there may be racial differences in the effects of T+O on lung function in patients with COPD.

METHODS

In this Tonado(®) subgroup analysis, we assessed efficacy and safety of T+O in Japanese participants.

RESULTS

Versus the overall population, the 413 Japanese patients randomized and treated were slightly older, with more men, lower body mass index, lower baseline St George's Respiratory Questionnaire (SGRQ) scores, fewer current smokers, but with higher pack-year smoking history. A lower proportion of Japanese patients used inhaled corticosteroids, short-acting muscarinic antagonists, or short- or long-acting β-adrenergic agonists at baseline, but use of long-acting muscarinic antagonists was higher. At Week 24, mean improvements with T+O 5/5 μg in forced expiratory volume in 1 second area under the curve from 0-3 hours response were 151 mL versus olodaterol and 134 mL versus tiotropium 5 μg; mean improvements with T+O 2.5/5 μg were 87 mL versus olodaterol and 70 mL versus tiotropium 2.5 μg. Mean improvements with T+O 5/5 μg in trough forced expiratory volume in 1 second were 131 mL versus olodaterol and 108 mL versus tiotropium 5 μg; mean improvements with T+O 2.5/5 μg were 60 mL versus olodaterol and 47 mL versus tiotropium 2.5 μg. SGRQ scores improved from baseline to a greater extent with both doses of T+O versus monotherapies. Responses were similar in the overall population. Adverse-event incidence was generally balanced across treatment groups.

CONCLUSION

Consistent with results from the overall population, T+O 5/5 μg was superior to each monotherapy for lung function and SGRQ in the Japanese sub-population of patients with COPD in Tonado(®).

Authors+Show Affiliations

Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.Department of Respiratory Medicine and Allergy, Tosei General Hospital, Aichi, Japan.Nippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan.Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA.Juntendo University School of Medicine, Tokyo, Japan.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27621608

Citation

Ichinose, Masakazu, et al. "The Efficacy and Safety of Combined Tiotropium and Olodaterol Via the Respimat(®) Inhaler in Patients With COPD: Results From the Japanese Sub-population of the Tonado(®) Studies." International Journal of Chronic Obstructive Pulmonary Disease, vol. 11, 2016, pp. 2017-27.
Ichinose M, Taniguchi H, Takizawa A, et al. The efficacy and safety of combined tiotropium and olodaterol via the Respimat(®) inhaler in patients with COPD: results from the Japanese sub-population of the Tonado(®) studies. Int J Chron Obstruct Pulmon Dis. 2016;11:2017-27.
Ichinose, M., Taniguchi, H., Takizawa, A., Grönke, L., Loaiza, L., Voβ, F., Zhao, Y., & Fukuchi, Y. (2016). The efficacy and safety of combined tiotropium and olodaterol via the Respimat(®) inhaler in patients with COPD: results from the Japanese sub-population of the Tonado(®) studies. International Journal of Chronic Obstructive Pulmonary Disease, 11, 2017-27. https://doi.org/10.2147/COPD.S110389
Ichinose M, et al. The Efficacy and Safety of Combined Tiotropium and Olodaterol Via the Respimat(®) Inhaler in Patients With COPD: Results From the Japanese Sub-population of the Tonado(®) Studies. Int J Chron Obstruct Pulmon Dis. 2016;11:2017-27. PubMed PMID: 27621608.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy and safety of combined tiotropium and olodaterol via the Respimat(®) inhaler in patients with COPD: results from the Japanese sub-population of the Tonado(®) studies. AU - Ichinose,Masakazu, AU - Taniguchi,Hiroyuki, AU - Takizawa,Ayako, AU - Grönke,Lars, AU - Loaiza,Lazaro, AU - Voβ,Florian, AU - Zhao,Yihua, AU - Fukuchi,Yoshinosuke, Y1 - 2016/08/29/ PY - 2016/9/14/entrez PY - 2016/9/14/pubmed PY - 2017/8/10/medline KW - COPD KW - bronchodilators KW - maintenance treatment SP - 2017 EP - 27 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 11 N2 - BACKGROUND: The efficacy and safety of once-daily tiotropium + olodaterol (T+O) maintenance treatment was demonstrated in the large, multinational, replicate, randomized, Phase III, Tonado(®) 1 (NCT01431274) and 2 (NCT01431287) studies in patients with moderate to very severe COPD. However, there may be racial differences in the effects of T+O on lung function in patients with COPD. METHODS: In this Tonado(®) subgroup analysis, we assessed efficacy and safety of T+O in Japanese participants. RESULTS: Versus the overall population, the 413 Japanese patients randomized and treated were slightly older, with more men, lower body mass index, lower baseline St George's Respiratory Questionnaire (SGRQ) scores, fewer current smokers, but with higher pack-year smoking history. A lower proportion of Japanese patients used inhaled corticosteroids, short-acting muscarinic antagonists, or short- or long-acting β-adrenergic agonists at baseline, but use of long-acting muscarinic antagonists was higher. At Week 24, mean improvements with T+O 5/5 μg in forced expiratory volume in 1 second area under the curve from 0-3 hours response were 151 mL versus olodaterol and 134 mL versus tiotropium 5 μg; mean improvements with T+O 2.5/5 μg were 87 mL versus olodaterol and 70 mL versus tiotropium 2.5 μg. Mean improvements with T+O 5/5 μg in trough forced expiratory volume in 1 second were 131 mL versus olodaterol and 108 mL versus tiotropium 5 μg; mean improvements with T+O 2.5/5 μg were 60 mL versus olodaterol and 47 mL versus tiotropium 2.5 μg. SGRQ scores improved from baseline to a greater extent with both doses of T+O versus monotherapies. Responses were similar in the overall population. Adverse-event incidence was generally balanced across treatment groups. CONCLUSION: Consistent with results from the overall population, T+O 5/5 μg was superior to each monotherapy for lung function and SGRQ in the Japanese sub-population of patients with COPD in Tonado(®). SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/27621608/The_efficacy_and_safety_of_combined_tiotropium_and_olodaterol_via_the_Respimat_®__inhaler_in_patients_with_COPD:_results_from_the_Japanese_sub_population_of_the_Tonado_®__studies_ L2 - https://dx.doi.org/10.2147/COPD.S110389 DB - PRIME DP - Unbound Medicine ER -