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Extrafine ICS/LABA Versus As-Needed SABA for Small Airway Dysfunction in Symptomatic Patients With Preserved Spirometry
Sponsor: Yi-Han Hsiao
Summary
This study evaluates whether 4 weeks of extrafine inhaled corticosteroid/long-acting β2-agonist (beclomethasone dipropionate/formoterol fumarate, BDP/FOR) therapy improves clinical, physiological, and type 2 inflammatory outcomes compared with as-needed short-acting β2-agonist (SABA, salbutamol) alone in symptomatic patients who have preserved conventional spirometry but impulse oscillometry (IOS)-defined small airway dysfunction (SAD) and small airway reversibility (SAR) after bronchodilator inhalation. Participants were randomized 1:1 to receive extrafine BDP/FOR plus as-needed salbutamol, or as-needed salbutamol alone, for 4 weeks. Symptom score (Asthma Control Test), spirometry, IOS parameters, type 2 inflammatory biomarkers (FeNO, blood eosinophils, IgE), and rescue medication use were assessed before and after treatment.
Official title: Effects of Extrafine Inhaled Corticosteroid/Long-Acting β2-Agonist Therapy on Small Airway Dysfunction and Type 2 Inflammatory Biomarkers in Symptomatic Patients With Preserved Spirometry
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
93
Start Date
2021-08-12
Completion Date
2024-11-29
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
Beclomethasone dipropionate/formoterol fumarate (extrafine)
Extrafine fixed-dose combination inhaler, 100 mcg beclomethasone dipropionate + 6 mcg formoterol fumarate dihydrate per actuation, 1 puff twice daily for 4 weeks. Arm(s): Extrafine BDP/FOR + as-needed SABA
Salbutamol
Short-acting β2-agonist metered-dose inhaler, 100 mcg/actuation, used as needed for symptom relief (max 200 mcg/use, max 4 times/day). Arm(s): As-needed SABA alone
Locations (1)
Taipei Veterans General Hospital, Department of Chest Medicine
Taipei, Taiwan