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

doi:10.1016/j.jaip.2020.09.066

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

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

15 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 language	English
Pages (from-to)	1304-1311.e2
Journal	Journal of Allergy and Clinical Immunology: In Practice
Volume	9
Issue number	3
DOIs	https://doi.org/10.1016/j.jaip.2020.09.066
State	Published - 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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10.1016/j.jaip.2020.09.066

Cite this

Cohort for Reality and Evolution of Adult Asthma in Korea (COREA) Study Group (2021). 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. Journal of Allergy and Clinical Immunology: In Practice, 9(3), 1304-1311.e2. https://doi.org/10.1016/j.jaip.2020.09.066

@article{d5539f31714a46ebbc0f09a46ddc4839,

title = "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",

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.",

keywords = "Asthma-COPD overlap, ICS, LABA, LAMA, Triple therapy",

author = "{Cohort for Reality and Evolution of Adult Asthma in Korea (COREA) Study Group} and Park, {So Young} and Solmi Kim and Kim, {Jung Hyun} and Kim, {Sae Hoon} and Taehoon Lee and Yoon, {Sun Young} and Kim, {Min Hye} and Moon, {Ji Yong} and Yang, {Min Suk} and Jung, {Jae Woo} and Kim, {Joo Hee} and Choi, {Jeong Hee} and Park, {Chan Sun} and Sujeong Kim and Jaechun Lee and Kwon, {Jae Woo} and Hur, {Gyu Young} and Kim, {Sang Ha} and Kim, {Hee Kyoo} and Shin, {Yoo Seob} and Kim, {Sang Hoon} and Nam, {Young Hee} and Jang, {An Soo} and Park, {Seo Young} and Kim, {Tae Bum} and Song, {Woo Jung} and Kwon, {Hyouk Soo} and Cho, {You Sook} and Moon, {Hee Bom} and Ki, {Tae Bum} and Bomi Seo and Choi, {Byoung Whui} and Cho, {Young Joo} and Park, {So Young} and Jin, {Hyun Jung} and Park, {Hye Kyung} and Lee, {Sang Min} and Kang, {Sung Yoon} and Ban, {Ga Young}",

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: {\textcopyright} 2020 American Academy of Allergy, Asthma & Immunology",

year = "2021",

month = mar,

doi = "10.1016/j.jaip.2020.09.066",

language = "English",

volume = "9",

pages = "1304--1311.e2",

journal = "Journal of Allergy and Clinical Immunology: In Practice",

issn = "2213-2198",

publisher = "Elsevier",

number = "3",

}

Cohort for Reality and Evolution of Adult Asthma in Korea (COREA) Study Group 2021, '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', Journal of Allergy and Clinical Immunology: In Practice, vol. 9, no. 3, pp. 1304-1311.e2. https://doi.org/10.1016/j.jaip.2020.09.066

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.
In: Journal of Allergy and Clinical Immunology: In Practice, Vol. 9, No. 3, 03.2021, p. 1304-1311.e2.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - A Randomized, Noninferiority Trial Comparing ICS + LABA with ICS + LABA + LAMA in Asthma-COPD Overlap (ACO) Treatment

T2 - The ACO Treatment with Optimal Medications (ATOMIC) Study

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

AU - Park, So Young

AU - Kim, Solmi

AU - Kim, Jung Hyun

AU - Kim, Sae Hoon

AU - Lee, Taehoon

AU - Yoon, Sun Young

AU - Kim, Min Hye

AU - Moon, Ji Yong

AU - Yang, Min Suk

AU - Jung, Jae Woo

AU - Kim, Joo Hee

AU - Choi, Jeong Hee

AU - Park, Chan Sun

AU - Kim, Sujeong

AU - Lee, Jaechun

AU - Kwon, Jae Woo

AU - Hur, Gyu Young

AU - Kim, Sang Ha

AU - Kim, Hee Kyoo

AU - Shin, Yoo Seob

AU - Kim, Sang Hoon

AU - Nam, Young Hee

AU - Jang, An Soo

AU - Park, Seo Young

AU - Kim, Tae Bum

AU - Song, Woo Jung

AU - Kwon, Hyouk Soo

AU - Cho, You Sook

AU - Moon, Hee Bom

AU - Ki, Tae Bum

AU - Seo, Bomi

AU - Choi, Byoung Whui

AU - Cho, Young Joo

AU - Park, So Young

AU - Jin, Hyun Jung

AU - Park, Hye Kyung

AU - Lee, Sang Min

AU - Kang, Sung Yoon

AU - Ban, Ga Young

N1 - 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

PY - 2021/3

Y1 - 2021/3

N2 - 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.

AB - 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.

KW - Asthma-COPD overlap

KW - ICS

KW - LABA

KW - LAMA

KW - Triple therapy

UR - http://www.scopus.com/inward/record.url?scp=85096385681&partnerID=8YFLogxK

U2 - 10.1016/j.jaip.2020.09.066

DO - 10.1016/j.jaip.2020.09.066

M3 - Article

C2 - 33184024

AN - SCOPUS:85096385681

SN - 2213-2198

VL - 9

SP - 1304-1311.e2

JO - Journal of Allergy and Clinical Immunology: In Practice

JF - Journal of Allergy and Clinical Immunology: In Practice

IS - 3

ER -

Cohort for Reality and Evolution of Adult Asthma in Korea (COREA) Study Group. 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. Journal of Allergy and Clinical Immunology: In Practice. 2021 Mar;9(3):1304-1311.e2. doi: 10.1016/j.jaip.2020.09.066

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

Abstract

Bibliographical note

Keywords

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