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
- 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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.