Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in Japan

Akira Umeda; Hisato Shimada; Tateki Yamane; Taichi Mochizuki; Yasushi Inoue; Kenji Tsushima; Kazuya Miyagawa; Atsumi Mochida; Hiroshi Takeda; Yasumasa Okada; Katsunori Masaki; Masako Matsusaka; Koichi Fukunaga

doi:10.3389/fphys.2023.1131949

Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in Japan

Front Physiol. 2023 Apr 21:14:1131949. doi: 10.3389/fphys.2023.1131949. eCollection 2023.

Authors

Akira Umeda^{1

2}, Hisato Shimada², Tateki Yamane³, Taichi Mochizuki⁴, Yasushi Inoue⁴, Kenji Tsushima⁵, Kazuya Miyagawa⁶, Atsumi Mochida⁶, Hiroshi Takeda⁷, Yasumasa Okada⁸, Katsunori Masaki⁹, Masako Matsusaka⁹, Koichi Fukunaga⁹

Affiliations

¹ Department of General Medicine, School of Medicine, International University of Health and Welfare (IUHW), IUHW Shioya Hospital, Yaita, Japan.
² Department of Respiratory Medicine, IUHW Shioya Hospital, Yaita, Japan.
³ Department of Digestive Organ, IUHW Shioya Hospital, Yaita, Japan.
⁴ Respiratory Diseases Center, IUHW Mita Hospital, Tokyo, Japan.
⁵ Department of Pulmonary Medicine, School of Medicine, International University of Health and Welfare, Narita, Japan.
⁶ Department of Pharmacology, School of Pharmacy, International University of Health and Welfare, Otawara, Japan.
⁷ Department of Pharmacology, School of Pharmacy at Fukuoka, International University of Health and Welfare, Fukuoka, Japan.
⁸ Department of Internal Medicine, National Hospital Organization Murayama Medical Center, Musashimurayama, Japan.
⁹ Division of Pulmonary Medicine, Department of Medicine, Keio University, Tokyo, Japan.

Abstract

Background: The Japanese drug use system allowed the once-daily use of inhaled corticosteroid fluticasone furoate (FF) combined with a long-acting beta-2 agonist vilanterol (VI) and a long-acting muscarinic antagonist umeclidinium (UMEC) against asthma on 18 February 2021. We investigated the real-world effects of these drugs (FF/UMEC/VI) mainly on lung function tests. Methods: This was an open-label, uncontrolled, within-group time-series (before-after) study. Prior asthma treatment (inhaled corticosteroid with/without a long-acting beta-2 agonist with/without a long-acting muscarinic antagonist) was switched to FF/UMEC/VI 200/62.5/25 μg. Subjects were evaluated by lung function tests prior to, and 1-2 months after, initiation of FF/UMEC/VI 200/62.5/25 μg. Patients were asked questions regarding the asthma control test and preference for drugs. Results: Overall, 114 asthma outpatients (97% Japanese) were enrolled from February 2021 to April 2022: 104 subjects completed the study. Forced expiratory volume in 1 s, peak flow, and asthma control test score of FF/UMEC/VI 200/62.5/25 μg-treated subjects were significantly increased (p < 0.001, p < 0.001, and p < 0.01, respectively). In contrast with FF/VI 200/25 μg, instantaneous flow at 25% of the forced vital capacity and expiratory reserve volume were significantly increased by FF/UMEC/VI 200/62.5/25 μg (p < 0.01, p < 0.05, respectively). Sixty-six percent of subjects declared they wanted to continue FF/UMEC/VI 200/62.5/25 μg in the future. Adverse effects, mainly local, were seen in 30% of patients, but no serious adverse effects were seen. Conclusion: Once-daily FF/UMEC/VI 200/62.5/25 μg was effective against asthma without serious adverse events. This is the first report that demonstrated FF/UMEC/VI dilated peripheral airways using lung function tests. This evidence on drug effects may improve our understanding of pulmonary physiology and the pathophysiology of asthma.

Keywords: asthma; fluticasone furoate; peripheral airways; small airways; umeclidinium; vilanterol.

Grants and funding

This study was partly supported by the International University of Health and Welfare.