This randomised, double-blind, placebo-controlled, three-period, crossover, phase II study found the fixed-dose combination of IND/GLY/MF (indacaterol acetate/ glycopyrronium bromide/mometasone furoate) to be safe and effective in asthma patients, irrespective of time of administration (morning or evening).

To evaluate the bronchodilator effect of IND/GLY/MF (150/50/80 μg) when used morning and evening as compared to placebo in patients with mild-moderate intensity asthma.

The weighted mean forced expiratory volume in 1 second (FEV₁) over 24 hours of IND/GLY/MF at dose of 150/50/80 μg at morning and evening for 2 weeks compared to placebo was regarded as the primary end-point. The consequence of dosing time on peak expiratory flow (PEF) and safety and tolerability were considered as the secondary outcomes.

Out of 37 patients aged 18 to 72 year, 34 patients accomplished all the 3 treatment phases. The median (range) pre-bronchodilator FEV₁ was 75.8% (60-96%) at the screening. About 83.8% patients were using steady low dose and 16.2% medium dose inhaled corticosteroid.

As compared to placebo, the morning and evening intake of IND/GLY/MF helped to improve the FEV₁ by 610 mL and 615 mL, correspondingly, as shown below:

Also, the patients in IND/GLY/MF group had elevated mean PEF by 70.7 L·min^-1 after morning dosage and by 59.7 L·min^-1 after evening dosage over 2 weeks. IND/GLY/MF was found safe as no serious adverse effects reported.

Inhaled IND/GLY/MF when used once everyday was safe, well tolerated and offered continued lung function improvements over 24 hours in patients with asthma.