Long-term safety of once-daily indacaterol acetate/glycopyrronium bromide/mometasone furoate high-dose, and indacaterol acetate/mometasone furoate high-dose, in Japanese patients with inadequately controlled asthma: Results from two open-label, 52-week studies

Abstract

Introduction

The 52-week long-term safety of once-daily indacaterol acetate/glycopyrronium bromide/mometasone furoate (IND/GLY/MF) high-dose (150/50/160 µg) and IND/MF high-dose (150/320 µg) was evaluated in two studies enrolling Japanese patients with inadequately controlled asthma.

Methods

Study 1 (IND/GLY/MF) and Study 2 (IND/MF) were 52-week, phase III, open-label, single-arm, multicenter studies conducted in Japanese adult patients with inadequately controlled asthma. The primary endpoint was incidence and severity of treatment-emergent adverse events (AEs) over 52-weeks.

Results

In Study 1, 94 patients received IND/GLY/MF high-dose and 84 (89.4%) patients completed the 52-week study treatment; in Study 2, 51 patients received IND/MF high-dose and 48 (94.1%) patients completed the 52-week study treatment. In Study 1, 68.1% and 6.4% of 94 patients reported ≥1 AE and ≥1 serious AE (SAE) respectively. In Study 2, 78.4% of 51 patients reported ≥1 AE; no patients reported SAEs. The most commonly reported AEs were asthma (exacerbation; 30.9% and 54.9%) and nasopharyngitis (18.1% and 29.4%) in Study 1 and Study 2, respectively. Severe AEs including asthma (exacerbation) were reported in 13.8% and 13.7% of patients in Study 1 and Study 2, respectively. In Study 1, 10 patients (10.6%) reported treatment-related AEs, of which dysphonia (9 patients [9.6%]) was the most commonly reported; no treatment-related AEs were reported in Study 2. In Study 1, one death (not study drug-related) was reported after study discontinuation (92 days after last dose of study medication).

Conclusions

Once-daily IND/GLY/MF and IND/MF high-dose were well-tolerated in Japanese patients with inadequately controlled asthma. No unexpected safety findings were observed.

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Keywords:

• Asthma control
• Japan
• long-acting β₂-adrenergic agonist/inhaled corticosteroid (LABA/ICS)
• long-acting β₂-adrenergic agonist/long-acting muscarinic antagonist/inhaled corticosteroid (LABA/LAMA/ICS)
• lung function
• safety

Acknowledgments

Authors thank all the patients and investigators who participated in the two studies. All authors were involved in drafting, writing, and reviewing the manuscript, and all authors read and approved the final manuscript. The authors thank Mohammed Najeeb Ashraf, Phani Dantu and Rahul Lad (Novartis Healthcare Pvt. Ltd. India) for providing medical writing support/editorial support, which was funded by Novartis, in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3). Authors also thank Hajime Yoshisue (Novartis Pharma K.K.) for their support on finalizing the manuscript.

Declaration of interest

Hironori Sagara received lecture fees from Astellas Pharma, AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Kyorin Pharma, Kracie Holdings and Novartis Pharma. Yoichi Nakamura received lecture fees (honoraria) from GlaxoSmithKline. Peter D’Andrea and Abhijit Pethe are employees of Novartis Pharmaceuticals Corporation, New Jersey, United States. Ana-Maria Tanase and Motoi Hosoe are employees of Novartis Pharma AG, Basel, Switzerland. Yukina Tanaka and Kazutaka Matsuo are employees of Novartis Pharma K.K, Tokyo, Japan.