Open-label, single-center, randamized and parallel-group study to compare the effect of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) and that of fluticasone propionate dry powder inhaler (FP-DPI) on large and small airways involvement in bronchial asthma.

Open-label, single-center, randamized and parallel-group study to compare the effect of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) and that of fluticasone propionate dry powder inhaler (FP-DPI) on large and small airways involvement in bronchial asthma. - Study to compare the effect of HFA-BDP and FP-DPI in bronchial asthma.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000983

Enrollment

Registered

2008-01-13

Start date

2008-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial asthma

Interventions

Hydrofluoroalkane-134a beclomethasone dipropionate 200 mcg bid 12 weeks Fluticasone propionate dry powder inhaler 200 mcg bid 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inhaled corticosteroids-naive mild-to-moderate asthmatic patients

Exclusion criteria

Exclusion criteria: 1 Current smokers 2 Past treatment with inhaled corticosteroids ever 3 Past treatment with oral corticosteroids in the previous 2 months 4 Intractable infection such as systemic fungal infection 5 Allergy to the drugs used in this study 6 Tuberculosis or other respiratory infection 7 Obstructive lung disease such as COPD or bronchiectasis 8 Adrenal insufficiency 9 Dependency on systemic steroids 10 Glaucoma or cataract 11 Pregnancy or lactation 12 Inappropriate patients from the doctor's viewpoint

Design outcomes

Primary

Measure	Time frame
Parameters of impulse oscillometry at 0, 4, 8 and 12 weeks. Indices of chest computed tomography at 0 and 12 weeks. Indices of continuous methacholine inhalation method at 0 and 12 weeks.	—

Secondary

Measure	Time frame
1 Values of pulmonary function at 0, 4, 8 and 12 weeks. 2 Inflammatory biomarkers of induced sputum at 0 and 12 weeks. 3 Exhaled nitric oxide concentration at 0 and 12 weeks. 4 Scores of questionnaires at 0 and 12 weeks. 5 Wheezing on auscultation at 0, 4, 8 and 12 weeks.	—

Countries

Japan

Contacts

Public ContactTomoshi Takeda

Kyoto University Graduate School of Medicine Department of Respiratory Medicine

075-751-3830

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026