Long-Acting Muscarinic Antagonist as an Alternative to Inhaled Corticosteroids in Type 2-Low Mild Asthma: A Randomized Crossover Non-inferiority Trial.
Noeul Kang, Eunse Kim, Sung-Cheol Yun et al.
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In 30 seconds
This multicenter, pragmatic, randomized, open-label crossover non-inferiority trial compared 6 months of long-acting muscarinic antagonist (LAMA) monotherapy with 6 months of inhaled corticosteroid (ICS) therapy in adults with T2-low mild asthma. Among 89 participants who completed both treatment phases, treatment success was 7.9 percentage points higher with LAMA (95% CI, -2.9 to 18.8; P < .001), meeting the trial’s non-inferiority criterion. However, non-inferiority was not established in an intention-to-treat analysis that counted all uncompleted phases as failures. Exacerbation rates did not differ significantly, and symptoms and lung function remained stable with both treatments.
Key findings
- In the per-protocol population, treatment success was 7.9 percentage points higher with LAMA (95% CI, -2.9 to 18.8; P < .001).
- Non-inferiority was not established when all uncompleted treatment phases were counted as failures (-3.3 percentage points; 95% CI, -11.3 to 4.5).
- Exacerbation rates did not differ significantly; symptom control and lung function remained stable across both treatment phases.
- The favorable effect of LAMA was more pronounced in participants aged less than 65 years.
Why it matters
Controller options for T2-low asthma are not well defined, and this trial suggests LAMA monotherapy may achieve treatment success comparable to ICS for some adults with mild disease. The differing results across missing-data analyses are important when interpreting the non-inferiority finding; the evidence supports consideration of an alternative, but does not establish equivalence across all patients or analyses.
What to keep in mind
Only 89 of 150 randomized participants completed both phases. Non-inferiority was not established in the intention-to-treat analysis that treated all uncompleted phases as failures, making the conclusion sensitive to missing-data assumptions.