Comparison of extrafine and non-extrafine inhaled corticosteroids/long-acting β-agonists as maintenance and reliever therapy in asthma: a randomized open-label crossover trial

Background/Aims Asthma is characterized by chronic inflammation. Inhaled corticosteroids (ICS) remain the cornerstone of anti-inflammatory therapy, targeting both the large and small airways. Methods This randomized open-label crossover trial included 30 patients receiving step 3 inhaled medication...

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Main Authors: Sang Pyo Lee, Sang Min Lee, Sung-Yoon Kang
Format: Article
Language:English
Published: The Korean Association of Internal Medicine 2025-05-01
Series:The Korean Journal of Internal Medicine
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Online Access:http://kjim.org/upload/kjim-2024-393.pdf
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author Sang Pyo Lee
Sang Min Lee
Sung-Yoon Kang
author_facet Sang Pyo Lee
Sang Min Lee
Sung-Yoon Kang
author_sort Sang Pyo Lee
collection DOAJ
description Background/Aims Asthma is characterized by chronic inflammation. Inhaled corticosteroids (ICS) remain the cornerstone of anti-inflammatory therapy, targeting both the large and small airways. Methods This randomized open-label crossover trial included 30 patients receiving step 3 inhaled medication according to the Global Initiative for Asthma (GINA). Patients received beclomethasone/formoterol (BDP/F) for maintenance and reliever therapy for 6 weeks, followed by budesonide/formoterol (BUD/F) for 6 weeks, or vice versa, with a 4-week washout period in between. Assessments at each visit included the Asthma Control Test (ACT), Asthma Control Questionnaire, Quality of Life Questionnaire for Adult Korean Asthmatics, and pulmonary function test. The primary endpoint was the change in forced expiratory flow between 25% and 75% of vital capacity (FEF25–75% pred). Results Twenty-four patients (15 females, mean age 39.3 years) completed the study. The changes in FEF25–75% pred were comparable between BDP/F and BUD/F (5.79 ± 38.34 vs. −1.36 ± 14.93, p = 0.399). No significant differences were observed between the BDP/F and BUD/F groups in terms of improvement in asthma control or quality of life. However, in the subgroup of patients with positive methacholine bronchial provocation tests, BDP/F significantly improved ACT scores compared to BUD/F (0.92 ± 2.25 vs. −1.31 ± 3.04, p = 0.044). Conclusions Our study demonstrated that extrafine ICS treatment provided no significant advantage over non-extrafine ICS in improving small airway obstruction or overall asthma control in moderate asthma. This suggests that factors other than particle size may contribute to treatment outcomes.
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spelling doaj-art-56fede14d4bf4ad2bfec7fe92202d0862025-08-20T03:48:10ZengThe Korean Association of Internal MedicineThe Korean Journal of Internal Medicine1226-33032005-66482025-05-0140349150110.3904/kjim.2024.393171023Comparison of extrafine and non-extrafine inhaled corticosteroids/long-acting β-agonists as maintenance and reliever therapy in asthma: a randomized open-label crossover trialSang Pyo Lee0Sang Min Lee1Sung-Yoon Kang2 Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea Division of Respiratory Disease and Allergy, Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, KoreaBackground/Aims Asthma is characterized by chronic inflammation. Inhaled corticosteroids (ICS) remain the cornerstone of anti-inflammatory therapy, targeting both the large and small airways. Methods This randomized open-label crossover trial included 30 patients receiving step 3 inhaled medication according to the Global Initiative for Asthma (GINA). Patients received beclomethasone/formoterol (BDP/F) for maintenance and reliever therapy for 6 weeks, followed by budesonide/formoterol (BUD/F) for 6 weeks, or vice versa, with a 4-week washout period in between. Assessments at each visit included the Asthma Control Test (ACT), Asthma Control Questionnaire, Quality of Life Questionnaire for Adult Korean Asthmatics, and pulmonary function test. The primary endpoint was the change in forced expiratory flow between 25% and 75% of vital capacity (FEF25–75% pred). Results Twenty-four patients (15 females, mean age 39.3 years) completed the study. The changes in FEF25–75% pred were comparable between BDP/F and BUD/F (5.79 ± 38.34 vs. −1.36 ± 14.93, p = 0.399). No significant differences were observed between the BDP/F and BUD/F groups in terms of improvement in asthma control or quality of life. However, in the subgroup of patients with positive methacholine bronchial provocation tests, BDP/F significantly improved ACT scores compared to BUD/F (0.92 ± 2.25 vs. −1.31 ± 3.04, p = 0.044). Conclusions Our study demonstrated that extrafine ICS treatment provided no significant advantage over non-extrafine ICS in improving small airway obstruction or overall asthma control in moderate asthma. This suggests that factors other than particle size may contribute to treatment outcomes.http://kjim.org/upload/kjim-2024-393.pdfasthmabeclomethasonebudesonideforced expiratory flow between 25% and 75% of vital capacitytreatment outcome
spellingShingle Sang Pyo Lee
Sang Min Lee
Sung-Yoon Kang
Comparison of extrafine and non-extrafine inhaled corticosteroids/long-acting β-agonists as maintenance and reliever therapy in asthma: a randomized open-label crossover trial
The Korean Journal of Internal Medicine
asthma
beclomethasone
budesonide
forced expiratory flow between 25% and 75% of vital capacity
treatment outcome
title Comparison of extrafine and non-extrafine inhaled corticosteroids/long-acting β-agonists as maintenance and reliever therapy in asthma: a randomized open-label crossover trial
title_full Comparison of extrafine and non-extrafine inhaled corticosteroids/long-acting β-agonists as maintenance and reliever therapy in asthma: a randomized open-label crossover trial
title_fullStr Comparison of extrafine and non-extrafine inhaled corticosteroids/long-acting β-agonists as maintenance and reliever therapy in asthma: a randomized open-label crossover trial
title_full_unstemmed Comparison of extrafine and non-extrafine inhaled corticosteroids/long-acting β-agonists as maintenance and reliever therapy in asthma: a randomized open-label crossover trial
title_short Comparison of extrafine and non-extrafine inhaled corticosteroids/long-acting β-agonists as maintenance and reliever therapy in asthma: a randomized open-label crossover trial
title_sort comparison of extrafine and non extrafine inhaled corticosteroids long acting β agonists as maintenance and reliever therapy in asthma a randomized open label crossover trial
topic asthma
beclomethasone
budesonide
forced expiratory flow between 25% and 75% of vital capacity
treatment outcome
url http://kjim.org/upload/kjim-2024-393.pdf
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