Open-label cross-over study to evaluate the amount of residual inhaled corticosteroid (hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) and fluticasone propionate dry powder inhaler (FP-DPI)) in the mouths of elderly asthmatic patients after each inhalation

UMIN ID: UMIN000001323

Registered date:25/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Asthma
• Date of first enrollment: 2008/07/01
• Target sample size: 22
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

After evaluating the outcome of HFA-BDP administration, switch to FP-DPI in an equivalent dose. 4 weeks after the switch evaluate its outcome in same way as HFA-BDP.
After evaluating the outcome of FP-DPI administration, switch to HFA-BDP in an equivalent dose. 4 weeks after the switch evaluate its outcome in same way as FP-DPI.

Outcome(s)

• Primary Outcome: the amount of residual inhaled corticosteroids in gargled fluids, peak inspiratory flow,
• Secondary Outcome: pharyngeal culture for candida, and patient questionnaires

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)any hypersensitivity history for steroids, 2)under treatment with oral steroids, 3)under desensitization or non-specific therapy which is newly initiated within 6 months before this study, 4)other coexisting chronic respiratory diseases except for chronic obstructive pulmonary disease (COPD), 5)severe hepatic or renal disease, heart failure, hematologic diseases, or other severe co-morbid disease, 6)under treatment for chronic respiratory infectious diseases, 7)expectation of poor drug compliance, 8)Inappropriate patients from the doctor's viewpoint

Related Information

• Primary Sponsor: JA Gifu Kouseiren Tohno-Kousei Hospital
• Secondary Sponsor: None
• Source(s) of Monetary Support: Japan Allergy Foundation,None