Study of Inhaled Glucocorticosteroid Administration in Asthma Patients

• Sponsor: Hamamatsu University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00559689
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Duration (Months): 15.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Budesonide,hydrofluoroalkane-beclomethasone dipropionate; Drug: Budesonide,hydrofluoroalkane-beclomethasone

Study Design

• Study Type: Observational
• Actual Enrollment: 24 participants
• Observational Model: Case-Crossover
• Time Perspective: Cross-Sectional
• Official Title: Phase 4 Study of Once-Daily Inhaled Glucocorticosteroid Administration in Asthma Patients
• Study Start Date: Nov 1, 2005
• Actual Study Completion Date: Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
1 receive once-daily administration of inhaled glucocorticosteroids at bedtime	Drug: Budesonide,hydrofluoroalkane-beclomethasone; once-daily administration at bedtime
2 receive twice-daily administration of inhaled glucocorticosteroids	Drug: Budesonide,hydrofluoroalkane-beclomethasone dipropionate; receive twice-daily administration

Outcome Measures

Primary Outcome Measures

1. once-daily administration of inhaled glucocorticosteroids can control airway inflammation [two-year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamamatsu University School of Medicine	Hamamatsu		Japan	431-3192

Sponsors and Collaborators

• Hamamatsu University

Investigators

• Study Chair: Kingo Chida, MD,PhD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00559689
• Other Study ID Numbers: Hamamatsu-17-43; H-17-43
• First Posted: Nov 16, 2007
• Last Update Posted: Mar 16, 2009
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: asthma patients; well-controlled
• Additional relevant MeSH terms: Asthma; Budesonide; Beclomethasone

Study Results

No Results Posted as of Mar 16, 2009