The journal of allergy and clinical immunology. In practice · 2026
Long-Acting Muscarinic Antagonist as an Alternative to Inhaled Corticosteroids in Type 2-Low Mild Asthma: A Randomized Crossover Non-inferiority Trial.
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Kang Noeul, Kim Eunse, Yun Sung-Cheol, Kwon Hyouk-Soo, Song Woo-Jung, Cho You Sook, Ban Ga-Young, Kim Min-Hye, Ahn Kyung-Min, Kim Sang-Ha, Kim Joo-Hee, Park So-Young, Park Hye Jung, Kim Sang Hoon, Park So Young, Park Chan Sun, An Jin, Kim Sujeong, Nam Young-Hee, Shim Ji-Su, Lee Jaechun, Moon Ji-Yong, Kwon Jae-Woo, Sohn Kyoung-Hee, Kim Sae-Hoon, Jang An-Soo, Kang Sung-Yoon, Lee Sang Min, Hur Gyu Young, Kim Byung Keun, Yang Min-Suk, Park Han Ki, Kim Tae-Bum
Аннотация
BACKGROUND: Type 2 (T2)-low asthma is often less responsive to ICS; however, optimal controller strategies for this phenotype remain inadequately defined.
OBJECTIVE: To evaluate whether long-acting muscarinic antagonists (LAMA) are non-inferior to ICS in patients with T2-low mild asthma.
METHODS: In this multicenter, pragmatic, randomized, open-label, crossover trial, adults with T2-low mild asthma (blood eosinophils <300/μL and either FeNO <25 part per billion or sputum eosinophils <3%) were randomized 1:1 to 6 months of ICS followed by 6 months of LAMA, or vice versa. The primary outcome was a composite treatment-success end point. Non-inferiority was established if the lower bound of the 95% CI for the success rate difference was greater than -10 percentage points.
RESULTS: Among 150 randomized patients, 89 completed both phases (per-protocol population). Treatment success was 7.9 percentage points higher with LAMA (95% CI, -2.9 to 18.8; P < .001), consistent with two intention-to-treat analyses (risk differences, 4.1-4.2 percentage points). In another intention-to-treat analysis in which all uncompleted phases were considered to be failures, non-inferiority was not established (-3.3 percentage points; 95% CI, -11.3 to 4.5), although it was supported under a non-responder imputation approach for missing data (one-sided P = .020). The favorable effect was more pronounced in patients aged less than 65 years. Exacerbation rates did not differ significantly, and symptom control and lung function remained stable across both phases.
CONCLUSION: In patients with T2-low mild asthma, LAMA monotherapy may be non-inferior to ICS and may be considered an alternative controller option for selected patients.
OBJECTIVE: To evaluate whether long-acting muscarinic antagonists (LAMA) are non-inferior to ICS in patients with T2-low mild asthma.
METHODS: In this multicenter, pragmatic, randomized, open-label, crossover trial, adults with T2-low mild asthma (blood eosinophils <300/μL and either FeNO <25 part per billion or sputum eosinophils <3%) were randomized 1:1 to 6 months of ICS followed by 6 months of LAMA, or vice versa. The primary outcome was a composite treatment-success end point. Non-inferiority was established if the lower bound of the 95% CI for the success rate difference was greater than -10 percentage points.
RESULTS: Among 150 randomized patients, 89 completed both phases (per-protocol population). Treatment success was 7.9 percentage points higher with LAMA (95% CI, -2.9 to 18.8; P < .001), consistent with two intention-to-treat analyses (risk differences, 4.1-4.2 percentage points). In another intention-to-treat analysis in which all uncompleted phases were considered to be failures, non-inferiority was not established (-3.3 percentage points; 95% CI, -11.3 to 4.5), although it was supported under a non-responder imputation approach for missing data (one-sided P = .020). The favorable effect was more pronounced in patients aged less than 65 years. Exacerbation rates did not differ significantly, and symptom control and lung function remained stable across both phases.
CONCLUSION: In patients with T2-low mild asthma, LAMA monotherapy may be non-inferior to ICS and may be considered an alternative controller option for selected patients.