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.

UMIN ID: UMIN000000983

Registered date:13/01/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Bronchial asthma
• Date of first enrollment: 2008/02/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: 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 Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Kyoto University Graduate School of Medicine
• Secondary Sponsor: None
• Source(s) of Monetary Support: Kyoto University Graduate School of Medicine,None