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An Open-label Crossover Comparative Investigator-Initiated Trial to Explore Involvement of Peak Inspiratory Flow in Clinical Effects of DPI

An Open-label Crossover Comparative Investigator-Initiated Trial to Explore Involvement of Peak Inspiratory Flow in Clinical Effects of DPI - A Comparative Study to Explore Involvement of Peak Inspiratory Flow in Clinical Effects of DPI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015610
Enrollment
8
Registered
2014-11-05
Start date
2014-10-30
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

Asthma

Interventions

During Treatment Period I (8 days
Visit 2, 3, 4), Impulse Oscillometry measurements are monitored over time (pre-dosing, at 0.5, 1, 2 hours post-dosing) before or after inhalation of Advair Diskus. During Treatment Period II (8 days
Visit 5, 6, 7), Impulse Oscillometry measurements are monitored as in Visit 2, 3, 4 after inhalation of Advair Aerosol. During Treatment Period I (8 days
Visit 2, 3, 4), Impulse Oscillometry measurements are monitored over time (pre-dosing, at 0.5, 1, 2 hours post-dosing) before or after inhalation of Advair Aerosol. During Treatment Period II (8 days
Visit 5, 6, 7), Impulse Oscillometry measurements are monitored as in Visit 2, 3, 4 after inhalation of Advair Diskus.

Sponsors

Medical Corporation Fukuwakai Fukuwa clinic
Lead Sponsor
THE DIVISION OF RESPIRATORY AND ALLERGY, DEPARTMENT OF INTERNAL MEDICINE
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Asthma and/or COPD outpatients with age more than 60 years irrespective of gender -Asthma and/or COPD outpatients with their PIF values of less than 90 L/min (including at least four patients with their PIF values of less than 60 L/min) -Patients who are prescribed Advair Diskus over the past four weeks in fixed doses

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactAbe, Kenji

Medical Corporation Fukuwakai Fukuwa clinic Statistics

kenji.abe.cp@clinipro.co.jp03-3243-0139

Outcome results

None listed

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