David Miller, J. Jauernig, S. Vaidya
Sep 28, 2019
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Quality indicators
Journal
Airway pharmacology and treatment
Abstract
Background: In the development of indacaterol (IND)/glycopyrronium/mometasone FDC for asthma, the maleate salt of IND was replaced by acetate to avoid post-inhalation cough. We investigated lung function, PK, and safety/tolerability of the two IND salt forms in patients with asthma. Methods: This was a randomized, double-blind, three-period cross-over study. Adult asthma patients with percentage predicted pre-bronchodilator FEV1 ≥50% and ≤90% received IND maleate 150µg od, IND acetate 150µg od and placebo on top of stable background ICS in randomised sequence. Primary endpoint was trough FEV1 after 14 days of treatment. Plasma PK were assessed at steady state after 14 days, while AEs were collected throughout the study. Results: In total, 51 patients (median age, 48 yrs) completed the study. Both IND salts significantly improved lung function vs placebo (Table). Systemic exposure to IND after inhalation of IND acetate and IND maleate were comparable (Table). Both salt forms were safe and well tolerated, with considerable difference in incidence of post-inhalation cough with IND acetate (maleate, 23.5%; acetate, 0%). Conclusions: In patients with asthma, indacaterol acetate and maleate elicited comparable and significant improvements in lung function and achieved comparable systemic exposure. Both indacaterol salts were safe and well tolerated. Indacaterol acetate was not associated with any post-inhalation cough.