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

Cohort for Reality and Evolution of Adult Asthma in Korea (COREA) Study Group

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18 Scopus citations

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 + long-acting β2 agonist (LABA) and ICS + LABA + 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 + LABA. In total, 303 patients were involved in the present trial, with 149 receiving ICS + LABA + 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 + LABA treatment group, 29 of 154 patients (18.83%) experienced exacerbation, whereas 28 of 149 patients (18.79%) experienced exacerbation in the ICS + LABA + 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 + LABA treatment is not inferior to ICS + LABA + LAMA in terms of exacerbation, it is obvious that the ICS + LABA + LAMA treatment group had improved lung function in ACO.

Original languageEnglish
Pages (from-to)1304-1311.e2
JournalJournal of Allergy and Clinical Immunology: In Practice
Volume9
Issue number3
DOIs
StatePublished - Mar 2021

Bibliographical note

Funding Information:
The study was conducted between August 2016 and February 2018 in 21 medical centers belonging to the Cohort for Reality and Evolution of Adult Asthma in Korea (COREA). The protocols were approved by the Institutional Review Board of Asan Medical Center (2016-0729), as well as each participating center. This trial is registered with the Clinical Research Information Service (KCT0002050). The present study was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health & Welfare, Republic of Korea (grant no. HC15C1335 ).

Funding Information:
The study was conducted between August 2016 and February 2018 in 21 medical centers belonging to the Cohort for Reality and Evolution of Adult Asthma in Korea (COREA). The protocols were approved by the Institutional Review Board of Asan Medical Center (2016-0729), as well as each participating center. This trial is registered with the Clinical Research Information Service (KCT0002050). The present study was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health & Welfare, Republic of Korea (grant no. HC15C1335).

Publisher Copyright:
© 2020 American Academy of Allergy, Asthma & Immunology

Keywords

  • Asthma-COPD overlap
  • ICS
  • LABA
  • LAMA
  • Triple therapy

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