Lower ICS dose effect on symptoms and rescue medication use of indacaterol/glycopyrronium/mometasone (IND/GLY/MF) medium-dose vs salmeterol/fluticasone (Sal/Flu) high-dose plus tiotropium (Tio): ARGON study

Abstract

Aim: Prior studies have confirmed the fast and sustained bronchodilation with IND and GLY¹, and improved lung function with MF². Here we evaluated the effect of IND/GLY/MF fixed-dose combination via Breezhaler^® vs Sal/Flu+Tio on symptoms and rescue medication use in uncontrolled asthma patients.

Methods: ARGON(NCT03158311) was a 24 wk, Phase 3b, multicentre, randomised, partially-blinded, non-inferiority, active-controlled study in symptomatic (ACQ-7 ≥1.5) patients (≥18 yrs). This exploratory analysis evaluated the effect of IND/GLY/MF medium-dose (150/50/80µg) o.d. vs combination of Sal/Flu high-dose (50/500µg) b.i.d. + Tio 5µg o.d. on symptom scores and rescue medication use at Wk 24.

Results: Reduction in total daily symptom scores (LSM treatment difference [Δ]: −0.103, p=0.119), percentage of nights without awakenings (Δ: 0.864, p=0.608) and reduction in rescue medication use (Δ: −0.134, p=0.081) with IND/GLY/MF medium-dose were comparable with Sal/Flu+Tio. Patients receiving IND/GLY/MF medium-dose had a higher percentage of days with no day-time symptoms (Δ: 4.453, p=0.016) and mornings with no symptoms (Δ: 4.976, p=0.012) vs Sal/Flu+Tio.

Conclusion: IND/GLY/MF medium-dose o.d. delivered via a single inhaler was comparable in terms of symptom scores and rescue medication use, while resulting in better improvements in day-time symptoms and morning symptoms vs Sal/Flu high-dose b.i.d. + Tio o.d. delivered via two inhalers, at a reduced ICS dose.

References:1.Rossi A. et al. Int J Chron Obstruct Pulmon Dis 2015;10:1383-92; 2.Kemp JP. et al. J Allergy Clin Immunol 2000;106:485-92