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
NCT ID NCT07809555
First seen Sep 09, 2026 · Last updated Sep 09, 2026
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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93 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Nov 2024
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥20 years * Chronic respiratory symptoms (cough, sputum, chest tightness, dyspnea, or wheezing) for ≥8 weeks * Preserved spirometry: FEV1/FVC ≥0.7, FVC ≥80% predicted, and negative bronchodilator reversibility (increase in FEV1 or FVC \<12% and \<200 mL after salbutamol) * IOS-defined small airway dysfunction and small airway reversibility (SAR): AX \>0.44 kPa/L with post-bronchodilator reduction in AX ≥35% after salbutamol inhalation Exclusion Criteria: * Age \<20 years * Impaired spirometry (FEV1/FVC \<0.7, FVC ≤80% predicted, or positive bronchodilator reversibility) * Absence of SAD or lack of significant SAR * Respiratory symptoms absent or \<8 weeks * Acute respiratory condition within 4 weeks before enrollment (upper/lower respiratory tract infection, acute exacerbation, pneumonia requiring antibiotics, ED visit or hospitalization) * Current diagnosis of COPD, chronic respiratory infection, or structural lung disease (active/prior tuberculosis, bronchiectasis, interstitial/restrictive lung disease, arteriovenous malformation, or prior pulmonary surgery) * Use of any bronchodilator (oral/inhaled), theophylline, steroid (inhaled/oral/IV), or beta-blocker within 4 weeks before enrollment * Known hypersensitivity to beclomethasone dipropionate/formoterol fumarate or salbutamol * Contraindication to pulmonary function testing or venous blood sampling (severe/unstable cardiovascular disease, recent major thoracic/abdominal surgery, unresolved pneumothorax, uncontrolled bronchospasm or hemoptysis, need for FiO2 \>50%, impaired consciousness or dementia) * Other physician-assessed unsuitability for pulmonary function testing or blood sampling * Incomplete informed consent * Known HIV/AIDS infection * Pregnant or breastfeeding women
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Taipei Veterans General Hospital, Department of Chest Medicine
Taipei, 11217, Taiwan