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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.
- Source :
-
The Journal of asthma : official journal of the Association for the Care of Asthma [J Asthma] 2023 Feb; Vol. 60 (2), pp. 403-411. Date of Electronic Publication: 2022 May 30. - Publication Year :
- 2023
-
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.<br />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.<br />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).<br />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.<br />Supplemental data for this article is available online at.
- Subjects :
- Adult
Humans
Administration, Inhalation
Adrenergic beta-2 Receptor Agonists therapeutic use
Bronchodilator Agents therapeutic use
Drug Combinations
East Asian People
Glycopyrrolate therapeutic use
Treatment Outcome
Acetates therapeutic use
Asthma drug therapy
Mometasone Furoate therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1532-4303
- Volume :
- 60
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- The Journal of asthma : official journal of the Association for the Care of Asthma
- Publication Type :
- Academic Journal
- Accession number :
- 35348408
- Full Text :
- https://doi.org/10.1080/02770903.2022.2056048