An Open-label Crossover Comparative Investigator-Initiated Trial to Explore Involvement of Peak Inspiratory Flow in Clinical Effects of DPI
Not Applicable
- Conditions
- AsthmaChronic Obstructive Pulmonary Disease
- Registration Number
- JPRN-UMIN000015610
- Lead Sponsor
- Medical Corporation Fukuwakai Fukuwa clinic
- Brief Summary
IOS data (R5, R20, R5-R20, X5, AX and Fres) showed a tendency which pMDI is more effective than dry powder inhaler in subjects with poor lung function. These data were well accorded with comments of the subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
Not provided
Exclusion Criteria
-Patients who use steroidal anti-inflammatory drugs -Patients who has developed respiratory infection in recent 6 weeks -Patients who are manifested by clinically abnormal laboratory values -Patients who are judged to be inappropriate as a subject by the clinical research director or the clinical research member
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Variations in Impulse Oscillometry Measurements (R5-R20, X5, AX, Fres) from Baseline at Two Hours Post Dosing by Using Advair Diskus or Advair Aerosol and The Relationship with Peak Inspiratory Flow (PIF)
- Secondary Outcome Measures
Name Time Method Efficacy -Variations in Impulse Oscillometry Measurements from Baseline at Thirty minutes, One Hour, Two Hours Post Inhalation of Advair Diskus -Variations in Impulse Oscillometry Measurements from Baseline at Thirty minutes, One Hour, Two Hours Post Inhalation of Advair Aerosol -Comparison Values on Variations in Impulse Oscillometry Measurements from Baseline at Thirty minutes, One Hour, Two Hours Post Inhalation of Advair Diskus or Advair Aerosol Safety -Laboratory Values, Adverse Events etc.