Lung function, pharmacokinetics, and tolerability of inhaled indacaterol maleate and acetate in asthma patients.

ABSTRACT: BACKGROUND:Indacaterol maleate delivered with the Breezhaler® inhalation device is a long-acting ?2-agonist approved for chronic obstructive pulmonary disease. In the development of a once daily, inhaled fixed dose combination (FDC) of indacaterol, glycopyrronium bromide (a long-acting muscarinic antagonist), and mometasone furoate (an inhaled corticosteroid [ICS]) for the treatment of patients with asthma, the acetate salt of indacaterol is used instead of the maleate salt. Here, we investigated the lung function, pharmacokinetics (PK) and safety of indacaterol maleate 150??g once daily (o.d.) and indacaterol acetate 150??g o.d. in comparison with placebo. METHODS:This was a randomised, double-blind, three-period crossover study (ClinicalTrials.gov identifier, NCT03257995) in patients with asthma on background ICS therapy. Patients with percent predicted pre-bronchodilator forced expiratory volume per second (FEV1) ?50% and???90% were included in the study. Patients received indacaterol maleate 150??g o.d., indacaterol acetate 150??g o.d., or placebo on top of stable background ICS in randomised sequence. Trough FEV1 was assessed after 14?days of treatment. PK of indacaterol salts were assessed at steady state after 14?days of treatment; peak expiratory flow (PEF) rate and rescue medication use were collected with a combined PEF-meter/electronic diary throughout the study. RESULTS:Of the 54 adult patients (median age of 48?years), 51 patients completed the study. Both indacaterol salts demonstrated statistically significant improvements in trough FEV1 of 186?mL (maleate) and 146?mL (acetate) compared with placebo (both P?

SUBMITTER: Miller D 

PROVIDER: S-EPMC7513528 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature