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COMPLETED
NCT07809555
PHASE4

Extrafine ICS/LABA Versus As-Needed SABA for Small Airway Dysfunction in Symptomatic Patients With Preserved Spirometry

Sponsor: Yi-Han Hsiao

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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