Open-label, single-center, randomized and parallel-group study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate on small airways involvement in asthma assessed using impulse oscillometry system.

UMIN ID: UMIN000000632

Registered date:09/03/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Bronchial asthma
• Date of first enrollment: 2005/05/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Hydrofluoroalkane-134a beclomethasone dipropionate 200 mcg bids 12 weeks
Chlorofluorocarbon dipropionate 400 mcg bid 12 weeks

Outcome(s)

• Primary Outcome: Parameters of impulse oscillometry system.
• Secondary Outcome: 1 Symptoms 2 Wheezing on auscultation 3 Methacholine airway responsiveness 4 Pulmonary function 5 Lung volume measurement 6 Inflammatory biomarkers of induced sputum and peripheral blood 7 Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1 Current smoker 2 Past treatment with inhaled corticosteroids 3 Receiving oral corticosteroids in the previous 2 months

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