Study of Inhaled Glucocorticosteroid Administration in Asthma Patients

once-daily inhaled glucocorticosteroids treatment can sufficiently control airway inflammation in asthma patients...

Date First Received: November 15, 2007

Last Updated: November 15, 2007

Verified by: Hamamatsu University, November 2007

Clinical Trial Phase: Phase 4 | Start Date: November 2005

Overall Status: Completed

Estimated Enrollment: 24

Brief Summary

Official Title: “Phase 4 Study of Once-Daily Inhaled Glucocorticosteroid Administration in Asthma Patients”

Condition Keyword(s):

once-daily inhaled glucocorticosteroids treatment can sufficiently control airway inflammation in asthma patients.

Study Type: Observational

Study Design: Case-Crossover, Cross-Sectional

Intervention(s) in this Clinical Trial

  • Drug: Budesonide,hydrofluoroalkane-beclomethasone dipropionate
    • receive twice-daily administration
  • Drug: Budesonide,hydrofluoroalkane-beclomethasone
    • once-daily administration at bedtime

Arms, Groups and Cohorts in this Clinical Trial

  • : 1
    • receive once-daily administration of inhaled glucocorticosteroids at bedtime
  • : 2
    • receive twice-daily administration of inhaled glucocorticosteroids

Outcome Measures for this Clinical Trial

Primary Measures

  • once-daily administration of inhaled glucocorticosteroids can control airway inflammation
    • Time Frame: two-year

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Receive ICS for one year or more, with no change in dose within the previous 8 weeks

Exclusion Criteria:

  • Two or more courses of oral corticosteroid in the previous 12 months
  • Admission to hospital due to asthma in the previous 6 months
  • Admission to the intensive care unit due to asthma at any time in the past
  • Current cigarette smoker.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Hamamatsu University

Overall Clinical Trial Officials and Contacts

Kingo Chida, MD,PhD Study Chair Unaffiliated  

Additional Information

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00559689

Study ID Number: Hamamatsu-17-43

ClinicalTrials.gov Identifier: NCT00559689

Health Authority: Japan: Institutional Review Board

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