A Randomized, Noninferiority Trial Comparing ICS thorn LABA with ICS plus LABA plus LAMA in Asthma-COPD Overlap (ACO) Treatment: The ACO Treatment with Optimal Medications (ATOMIC) Study

Abstract

BACKGROUND: Current guidelines for the treatment of asthma and chronic obstructive pulmonary disease overlap (ACO) recommend initial treatment using inhaled corticosteroids (ICSs) plus 1 or more bronchodilators. OBJECTIVE: To clarify which therapeutic effect is better between the ICS D long-acting beta(2) agonist (LABA) and ICS D LABA D long-acting muscarinic antagonist (LAMA) treatment in patients with ACO. METHODS: We conducted a multicenter, 48-week, randomized, noninferiority trial. Patients with ACO were enrolled if they were treated with a moderate to high dose of ICS D LABA. In total, 303 patients were involved in the present trial, with 149 receiving ICS D LABA D LAMA. The primary end point was the time to first exacerbation. Secondary outcomes included changes in FEV1, forced vital capacity, FEV1/forced vital capacity ratio, asthma control, blood eosinophil count, and fractional exhaled nitric oxide. RESULTS: In the ICS D LABA treatment group, 29 of 154 patients (18.83%) experienced exacerbation, whereas 28 of 149 patients (18.79%) experienced exacerbation in the ICS D LABA D LAMA treatment group. The results of this noninferiority study were ultimately inconclusive (hazard ratio, 1.1; 95% CI, 0.66-1.84). However, the patients treated with the addition of LAMA showed significant improvements in FEV1 and forced vital capacity (P <.001). Asthma control did not improve in either group. CONCLUSIONS: Although this study was unable to conclude that ICS D LABA treatment is not inferior to ICS D LABA D LAMA in terms of exacerbation, it is obvious that the ICS D LABADLAMA treatment group had improved lung function in ACO. (C) 2020 American Academy of Allergy, Asthma & Immunology