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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.
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.
ERJ Open Research
Lung function improvements following inhaled indacaterol/glycopyrronium/mometasone furoate are independent of dosing time in asthma patients: a randomised trial
Jutta Beier al.
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