Efficacy and safety of extrafine glycopyrronium bromide (GB) in uncontrolled asthmatic patients

Paggiaro, Pierluigi; Georges, George; Scuri, Mario; Valente, Ilaria; Guasconi, Alessandro; Corre, Sandrine; Papi, Alberto

doi:10.1183/13993003.congress-2018.pa1027

Airway Pharmacology and Treatment 2018

DOI: 10.1183/13993003.congress-2018.pa1027

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Efficacy and safety of extrafine glycopyrronium bromide (GB) in uncontrolled asthmatic patients

Pierluigi Paggiaro

George Georges

Mario Scuri

et al.

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2021

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“…Indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF) delivered via the Breezhaler ® device (IND/GLY/MF) is a fixed-dose combination (FDC) of IND, a LABA, GLY, a LAMA, and MF, an ICS, in development for o.d.-maintenance treatment of asthma GINA (Step ≥ 4). Each of these three monocomponents, IND [8][9][10], GLY [11,12] and MF [13,14] have previously been approved as individual drugs for either chronic obstructive pulmonary disease (COPD) or asthma. Ethnic factors are known to contribute to differences in pharmacokinetics (PK) and pharmacodynamics of a number of drugs, thereby, resulting in variations in the treatment response [15][16][17].…”

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Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects

et al. 2021

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Background A once-daily (o.d.) fixed-dose combination of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF) delivered via the Breezhaler® device (IND/GLY/MF) is being developed for treatment of asthma. This study compared steady-state pharmacokinetics of IND, GLY and MF between Japanese and Caucasian male subjects after multiple inhalations of IND/GLY/MF o.d. Methods This was a single-center, open-label, 2-treatment crossover study with a 21-day washout period. Japanese and Caucasian subjects received IND/GLY/MF 150/50/80 μg (inhaled corticosteroid [ICS] medium-dose) or 150/50/160 μg o.d. (ICS high-dose) for 14 days in each period. Pharmacokinetics were characterized up to 24 h post-dose on Days 1 and 14. Results In total, 16 Japanese (median age 31 years [range 20–40 years], mean weight 68.3 kg) and 17 Caucasian subjects (median age 27 years [range 21–43 years], mean weight 75.0 kg) were randomized. Geometric mean ratios (Japanese/Caucasian) [90% confidence interval (CI)] for Cmax for IND, GLY and MF at the high ICS dose on Day 14 were 1.31 [1.13, 1.51] 1.38 [1.13, 1.69] and 1.07 [0.969, 1.18], respectively. Geometric mean ratios (Japanese/Caucasian) [90% CI] for AUC0–24h on Day 14 for IND, GLY and MF at the high ICS dose were 1.17 [1.01, 1.35], 1.05 [0.920, 1.20] and 1.15 [1.05, 1.27] respectively. Similar trends were noted for all components for the medium ICS dose treatment. IND/GLY/MF was safe and well tolerated; no AEs suspected to be study drug-related were observed. Conclusion Pharmacokinetics of IND, GLY and MF (high and medium dose) when delivered as a fixed-dose combination were comparable between Japanese and Caucasian subjects. The IND/GLY/MF combination at the administrated doses was safe and well tolerated in both ethnic groups. Trial registration Japan Registry of Clinical Trial: jRCT2031200227, retrospectively registered on 04, December, 2020.

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Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects

et al. 2021

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Efficacy and safety of extrafine glycopyrronium bromide (GB) in uncontrolled asthmatic patients

Cited by 1 publication

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Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects

Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects

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