Long-Acting Muscarinic Antagonist as an Alternative to Inhaled Corticosteroids in Type 2-Low Mild Asthma: A Randomized Crossover Non-inferiority Trial.

Authors

Noeul Kang, Eunse Kim, Sung-Cheol Yun, Hyouk-Soo Kwon, Woo-Jung Song, You Sook Cho, Ga-Young Ban, Min-Hye Kim, Kyung-Min Ahn, Sang-Ha Kim, Joo-Hee Kim, So-Young Park, Hye Jung Park, Sang Hoon Kim, So Young Park, Chan Sun Park, Jin An, Sujeong Kim, Young-Hee Nam, Ji-Su Shim, Jaechun Lee, Ji-Yong Moon, Jae-Woo Kwon, Kyoung-Hee Sohn, Sae-Hoon Kim, An-Soo Jang, Sung-Yoon Kang, Sang Min Lee, Gyu Young Hur, Byung Keun Kim, Min-Suk Yang, Han Ki Park, Tae-Bum Kim

Published in

The journal of allergy and clinical immunology. In practice. Aug 14, 2026. Epub Aug 14, 2026.

Abstract

Type 2 (T2)-low asthma is often less responsive to inhaled corticosteroids (ICS); however, optimal controller strategies for this phenotype remain inadequately defined.
To evaluate whether long-acting muscarinic antagonists (LAMA) are non-inferior to ICS in patients with T2-low mild asthma.
In this multicenter, pragmatic, randomized, open-label, crossover trial, adults with T2-low mild asthma (blood eosinophils <300/μL, and either FeNO <25 ppb 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 endpoint. Non-inferiority was established if the lower bound of the 95% confidence interval (CI) for the success rate difference was greater than -10 percentage points.
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<0.001), consistent with two intention-to-treat analyses (risk differences, 4.1-4.2 percentage points). In another intention-to-treat analysis where all uncompleted phases were considered as failures, non-inferiority was not established (-3.3 percentage points; 95% CI, -11.3 to 4.5), though it was supported under a non-responder imputation approach for missing data (one-sided P = 0.020). The favorable effect was more pronounced in patients aged <65 years. Exacerbation rates did not differ significantly, and symptom control and lung function remained stable across both phases.
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.

PMID:
42600984
Bibliographic data and abstract were imported from PubMed on 15 Aug 2026.

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