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Bronchodilator efficacy of tiotropium/formoterol (18/12 µg once daily via a Discair inhaler), tiotropium alone (18 µg by Handihaler) or combined with formoterol (12 µg twice daily by Aerolizer) in adults with moderate-to-severe stable COPD.
Curr Med Res Opin. 2019 12; 35(12):2187-2196.CM

Abstract

Objectives:

The bronchodilator efficacy of a once-daily fixed-dose combination of tiotropium/formoterol (18/12 µg administered via a dry-powder inhaler, Discair) [TIO/FORMfixed group] vs a single-dose of tiotropium (18 µg) by Handihaler1 alone [TIOmono group], or combined with formoterol 12 µg twice-daily by Aerolizer2 [TIO/FORMbid group] was compared in patients with moderate-to-severe stable COPD.

Methods:

COPD patients were randomized (28 patients/group) to receive TIO/FORMfixed, TIOmono, or TIO/FORMbid. AUC for the changes in FEV1 and FVC over a 24-h period; bronchodilator response (100 ml improvement in FEV1) in the first 30 min; maximum changes in FEV1 and FVC; and safety data were recorded. The primary endpoint was to confirm the non-inferiority of TIO/FORMfixed vs TIO/FORMbid in terms of the AUC for the changes in FEV1 over a 24-h period.

Results:

Changes in AUC0-24h for FEV1 and FVC were similar for TIO/FORMfixed and TIO/FORMbid, and were superior to TIOmono (p < 0.001). A positive bronchodilator response at 30 min was demonstrated in 50%, 64%, and 71% of patients in the TIOmono, TIO/FORMbid, and TIO/FORMfixed groups, respectively (NS). Maximum FEV1 and FVC changes were measured as 0.25/0.41 L, 0.32/0.49 L, and 0.37/0.53 L, for TIOmono, TIO/FORMbid, and TIO/FORMfixed, respectively (FEV1: TIO/FORMfixed vs TIOmono, p = 0.0017 and TIO/FORMfixed vs TIO/FORMbid, p = 0.4846); no differences were recorded between the combination groups.

Conclusions:

The 24-h bronchodilator efficacy of TIO/FORMfixed 18/12 µg once-daily by Discair3 was non-inferior to a combination of tiotropium 18 µg by Handihaler plus formoterol 12 µg twice-daily by Aerolizer, and superior to tiotropium 18 µg monotherapy by Handihaler.

Authors+Show Affiliations

Department of Pulmonary Medicine, Yedikule Research and Training Center for Chest Diseases and Thoracic Surgery, University of Health Sciences, Istanbul, Turkey.Department of Pulmonary Medicine, Yedikule Research and Training Center for Chest Diseases and Thoracic Surgery, University of Health Sciences, Istanbul, Turkey.Department of Chest Diseases and Thoracic Surgery, Sureyyapasa Training and Research Center for Chest Diseases and Thoracic Surgery, Istanbul, Turkey.

Pub Type(s)

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

Language

eng

PubMed ID

31397184

Citation

Yildiz, Birsen Pinar, et al. "Bronchodilator Efficacy of Tiotropium/formoterol (18/12 Μg once Daily Via a Discair Inhaler), Tiotropium Alone (18 Μg By Handihaler) or Combined With Formoterol (12 Μg Twice Daily By Aerolizer) in Adults With Moderate-to-severe Stable COPD." Current Medical Research and Opinion, vol. 35, no. 12, 2019, pp. 2187-2196.
Yildiz BP, Bayraktaroglu M, Gunen H. Bronchodilator efficacy of tiotropium/formoterol (18/12 µg once daily via a Discair inhaler), tiotropium alone (18 µg by Handihaler) or combined with formoterol (12 µg twice daily by Aerolizer) in adults with moderate-to-severe stable COPD. Curr Med Res Opin. 2019;35(12):2187-2196.
Yildiz, B. P., Bayraktaroglu, M., & Gunen, H. (2019). Bronchodilator efficacy of tiotropium/formoterol (18/12 µg once daily via a Discair inhaler), tiotropium alone (18 µg by Handihaler) or combined with formoterol (12 µg twice daily by Aerolizer) in adults with moderate-to-severe stable COPD. Current Medical Research and Opinion, 35(12), 2187-2196. https://doi.org/10.1080/03007995.2019.1654722
Yildiz BP, Bayraktaroglu M, Gunen H. Bronchodilator Efficacy of Tiotropium/formoterol (18/12 Μg once Daily Via a Discair Inhaler), Tiotropium Alone (18 Μg By Handihaler) or Combined With Formoterol (12 Μg Twice Daily By Aerolizer) in Adults With Moderate-to-severe Stable COPD. Curr Med Res Opin. 2019;35(12):2187-2196. PubMed PMID: 31397184.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bronchodilator efficacy of tiotropium/formoterol (18/12 µg once daily via a Discair inhaler), tiotropium alone (18 µg by Handihaler) or combined with formoterol (12 µg twice daily by Aerolizer) in adults with moderate-to-severe stable COPD. AU - Yildiz,Birsen Pinar, AU - Bayraktaroglu,Mesut, AU - Gunen,Hakan, Y1 - 2019/09/16/ PY - 2019/8/10/pubmed PY - 2020/7/11/medline PY - 2019/8/10/entrez KW - COPD KW - bronchodilator efficacy KW - fixed-dose combination KW - formoterol KW - tiotropium SP - 2187 EP - 2196 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 35 IS - 12 N2 - Objectives: The bronchodilator efficacy of a once-daily fixed-dose combination of tiotropium/formoterol (18/12 µg administered via a dry-powder inhaler, Discair) [TIO/FORMfixed group] vs a single-dose of tiotropium (18 µg) by Handihaler1 alone [TIOmono group], or combined with formoterol 12 µg twice-daily by Aerolizer2 [TIO/FORMbid group] was compared in patients with moderate-to-severe stable COPD.Methods: COPD patients were randomized (28 patients/group) to receive TIO/FORMfixed, TIOmono, or TIO/FORMbid. AUC for the changes in FEV1 and FVC over a 24-h period; bronchodilator response (100 ml improvement in FEV1) in the first 30 min; maximum changes in FEV1 and FVC; and safety data were recorded. The primary endpoint was to confirm the non-inferiority of TIO/FORMfixed vs TIO/FORMbid in terms of the AUC for the changes in FEV1 over a 24-h period.Results: Changes in AUC0-24h for FEV1 and FVC were similar for TIO/FORMfixed and TIO/FORMbid, and were superior to TIOmono (p < 0.001). A positive bronchodilator response at 30 min was demonstrated in 50%, 64%, and 71% of patients in the TIOmono, TIO/FORMbid, and TIO/FORMfixed groups, respectively (NS). Maximum FEV1 and FVC changes were measured as 0.25/0.41 L, 0.32/0.49 L, and 0.37/0.53 L, for TIOmono, TIO/FORMbid, and TIO/FORMfixed, respectively (FEV1: TIO/FORMfixed vs TIOmono, p = 0.0017 and TIO/FORMfixed vs TIO/FORMbid, p = 0.4846); no differences were recorded between the combination groups.Conclusions: The 24-h bronchodilator efficacy of TIO/FORMfixed 18/12 µg once-daily by Discair3 was non-inferior to a combination of tiotropium 18 µg by Handihaler plus formoterol 12 µg twice-daily by Aerolizer, and superior to tiotropium 18 µg monotherapy by Handihaler. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/31397184/Bronchodilator_efficacy_of_tiotropium/formoterol__18/12_µg_once_daily_via_a_Discair_inhaler__tiotropium_alone__18_µg_by_Handihaler__or_combined_with_formoterol__12_µg_twice_daily_by_Aerolizer__in_adults_with_moderate_to_severe_stable_COPD_ DB - PRIME DP - Unbound Medicine ER -