A Phase 4 interventional study of Beclomethasone dipropionate/formoterol fumarate (extrafine) and Salbutamol in Small Airway Dysfunction, sponsored by Yi-Han Hsiao. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Yi-Han Hsiao · Phase 4, Interventional, and Treatment
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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.
Symptomatic patients with asthma-like respiratory symptoms may have preserved conventional spirometry (FEV1/FVC ≥ 0.7, FVC ≥ 80% predicted, negative bronchodilator reversibility) yet still exhibit small airway dysfunction detectable only by impulse oscillometry (IOS). This prospective, single-center, open-label, randomized controlled trial enrolled adult patients (≥20 years) with chronic respiratory symptoms ≥8 weeks, preserved spirometry, IOS-defined SAD, and small airway reversibility (SAR), defined as AX > 0.44 kPa/L with a post-bronchodilator reduction in AX ≥35% after salbutamol 400 µg. Eligible participants were randomized 1:1 to receive either extrafine beclomethasone dipropionate/formoterol fumarate (100 mcg/6 mcg, 1 puff twice daily) plus as-needed salbutamol, or as-needed salbutamol alone (100 mcg, up to 200 mcg per use, maximum 4 times daily), for 4 weeks. Outcomes assessed before and after treatment included Asthma Control Test (ACT) score, spirometry (FEV1, FVC), IOS parameters (R5-R20, resonant frequency [Fres], reactance at 5Hz [X5], reactance area [AX]) with pre/post-bronchodilator change, fractional exhaled nitric oxide (FeNO), blood eosinophil count, serum total IgE, and frequency of rescue SABA use. The primary endpoint was the between-group difference in change of IOS parameters after 4 weeks of treatment; secondary endpoints included changes in symptom score, conventional spirometry, and inflammatory biomarkers, as well as treatment safety and tolerability.
This is the only study on the registry with Yi-Han Hsiao as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Extrafine beclomethasone dipropionate 100 mcg/formoterol fumarate dihydrate 6 mcg (Foster®), 1 inhalation twice daily for 4 weeks, plus salbutamol 100 mcg as needed (max 200 mcg/use, max 4 times/day). Assigned Intervention: Drug: Beclomethasone dipropionate/formoterol fumarate (extrafine)
Drug: Beclomethasone dipropionate/formoterol fumarate (extrafine) · Drug: Salbutamol
Salbutamol 100 mcg as needed (max 200 mcg/use, max 4 times/day) for 4 weeks, without ICS/LABA. Assigned Intervention: Drug: Salbutamol
Drug: Salbutamol
Drug pages: Beclomethasone · Formoterol
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
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
Change in Airway Resistance Difference (R5-R20) After 4 Weeks of Treatment
Between-group difference in change from baseline in the difference between resistance at 5 Hz and resistance at 20 Hz (R5-R20), measured by impulse oscillometry. Unit of measure: kPa/(L/s).
Time frame: Baseline (Visit 1) and Week 4 (Visit 2)
Change in Resonant Frequency (Fres) After 4 Weeks of Treatment
Between-group difference in change from baseline in resonant frequency (Fres), measured by impulse oscillometry. Unit of measure: Hz.
Time frame: Baseline (Visit 1) and Week 4 (Visit 2)
Change in Reactance at 5 Hz (X5) After 4 Weeks of Treatment
Between-group difference in change from baseline in reactance at 5 Hz (X5), measured by impulse oscillometry. Unit of measure: kPa/(L/s).
Time frame: Baseline (Visit 1) and Week 4 (Visit 2)
Change in Reactance Area (AX) After 4 Weeks of Treatment
Between-group difference in change from baseline in reactance area (AX), measured by impulse oscillometry. Unit of measure: kPa/L.
Time frame: Baseline (Visit 1) and Week 4 (Visit 2)
Change in Asthma Control Test (ACT) Score
Change in Asthma Control Test (ACT) Score. The ACT is a 5-item scale (score range 5-25), with higher scores indicating better asthma symptom control.
Time frame: Baseline and Week 4
Change in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Baseline and Week 4
Change in Spirometric Parameters (FEV1, FVC)
Time frame: Baseline and Week 4
Change in Type 2 Inflammatory Biomarkers (Blood Eosinophil Count, Serum Total IgE)
Time frame: Baseline and Week 4
Frequency of Rescue SABA Use
Puffs of salbutamol per day, number of days requiring rescue medication, and number of weeks with SABA use ≥2 puffs/week during the 4-week treatment period.
Time frame: 4 weeks
Plan to share: No
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Ran from Aug 2021 to primary completion in Nov 2024, 39 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Beclomethasone · Formoterol