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NCT00627731 Clinical Trial

Oral Glucocorticosteroid in the Treatment of Severe Asthma Exacerbation in Hospitalized Patients

Asthma Clinical Trial

Official title:
Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00627731
Other study ID # Hamamatsu-18-68
Secondary ID Hamamatsu-1968
Status Completed
Phase Phase 4
First received February 22, 2008
Last updated September 5, 2011
Start date June 2007
Est. completion date October 2009

Study information
Verified date October 2009
Source Hamamatsu University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

A comparison of oral prednisolone administration with intravenous methylprednisolone infusion in the treatment of acute asthma exacerbation in hospitalized patients. Oral glucocorticosteroids administration may be effective as intravenous high-dose methylprednisolone infusion.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 80 Years
Eligibility Inclusion Criteria:

- Asthma patients, who need hospitalized treatment, who do not respond with initial treatment including bronchodilator and IV methylprednisolone therapy

Exclusion Criteria:

- Need for incubation

- With severe complications

- Received systemic glucocorticosteroid therapy in the previous 4 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• methylprednisolone sodium succinate (mPSL)
mPSL IV 240mg per day for 5 days and oral PSL 40mg per day for 5 days
• prednisolone (PSL)
PSL 40 mg per day for 10 days

Locations
Country Name City State
Japan Hamamatsu University School of Medicine Hamamatsu

Sponsors (1)
Lead Sponsor Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of oral prednisolone for the treatment of acute asthma three-year Yes
Secondary The safety of oral prednisolone for the treatment of acute asthma three-year Yes
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