Clinical Interpretation of Efficacy Outcomes in Pharmacological Studies on Triple Fixed-Dose Combination Therapy for Uncontrolled Asthma: Assessment of IRIDIUM and ARGON Studies

Figures & data

Table 1 Clinical effect of MF/IND/GLY FDC administered at different ICS doses compared to active comparators on efficacy outcomes in asthmatic patients as reported in the IRIDIUM⁵ and ARGON⁶ studies

Outcome	Treatment	Active comparator	Delta	Suggested MCID	Beneficial clinically relevant effect
FEV1	MD-MF/IND/GLY	MD-MF/IND	76 mL	>60 mL*	Yes
	MD-MF/IND/GLY	HD-FLU/SAL	99 mL		Yes
	HD-MF/IND/GLY	HD-MF/IND	65 mL		Yes
	HD-MF/IND/GLY	HD-FLU/SAL	119 mL		Yes
	HD-MF/IND/GLY	HD-FLU/SAL + TIO	96 mL		Yes
Morning PEF	HD-MF/IND/GLY	HD-FLU/SAL + TIO	26.67%	>5.39%^#	Yes
Evening PEF	HD-MF/IND/GLY	HD-FLU/SAL + TIO	28.72%		Yes
All exacerbations (mild, moderate, and severe)	MD-MF/IND/GLY	HD-FLU/SAL	−30%	>-20%	Yes
	HD-MF/IND/GLY	HD-MF/IND	−21%		Yes
	HD-MF/IND/GLY	HD-FLU/SAL	−40%		Yes
Moderate or severe exacerbations	MD-MF/IND/GLY	HD-FLU/SAL	−19%		Borderline
	HD-MF/IND/GLY	HD-FLU/SAL	−36%		Yes
Moderate exacerbations	HD-MF/IND/GLY	HD-FLU/SAL + TIO	−43%		Yes
Severe exacerbations	HD-MF/IND/GLY	HD-MF/IND	−22%		Yes
	HD-MF/IND/GLY	HD-FLU/SAL	−42%		Yes
ACQ-7	HD-MF/IND/GLY	HD-FLU/SAL	+8.2% responders	>0.5 points	A greater proportion of patients achieved the MCID
AQLQ	HD-MF/IND/GLY	HD-FLU/SAL + TIO	+8.1% responders	>0.5 points	A greater proportion of patients achieved the MCID
SGRQ	HD-MF/IND/GLY	HD-FLU/SAL + TIO	−2.00	>4 units	No

Notes: * vs. active treatment. ^#Assessed via MPPI.

Abbreviations: ACQ-7, Asthma Control Questionnaire 7; AQLQ, Quality of Life Questionnaire; FEV₁, forced expiratory volume in 1 s; FDC, fixed-dose combination; FLU, fluticasone; GLY, glycopyrronium; HD, high-dose; ICS, inhaled corticosteroid; IND, indacaterol; MD, medium-dose; MCID, minimal clinically important difference; MF, mometasone furoate; MPPI, minimal patient perceivable improvement; PEF, peak expiratory flow; SAL, salmeterol; SGRQ, St. George’s Respiratory Questionnaire; TIO, tiotropium.

Kerstjens HAM, Maspero J, Chapman KR, et al. Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled Phase 3 study. Lancet Respir Med. 2020;8:1000–1012. doi:10.1016/S2213-2600(20)30190-9

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Gessner C, Kornmann O, Maspero J, et al. Fixed-dose combination of indacaterol/glycopyrronium/mometasone furoate once-daily versus salmeterol/fluticasone twice-daily plus tiotropium once-daily in patients with uncontrolled asthma: a randomised, Phase IIIb, non-inferiority study (ARGON). Respir Med. 2020;170:106021. doi:10.1016/j.rmed.2020.106021

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