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

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: methylprednisolone sodium succinate (mPSL); Drug: prednisolone (PSL)

• Registration Number: NCT00627731
• Lead Sponsor: Hamamatsu University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-02-29
• Study First Posted: 2008-03-03
• Status Verified: 2009-10
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2011-09-05
• Last Update Posted: 2011-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	methylprednisolone sodium succinate (mPSL)	mPSL 240 mg per day for 5 days
2	prednisolone (PSL)	PSL 40mg per day for 10 days

Primary Outcome Measures

Name	Time	Method
Efficacy of oral prednisolone for the treatment of acute asthma	three-year

Secondary Outcome Measures

Name	Time	Method
The safety of oral prednisolone for the treatment of acute asthma	three-year

Trial Locations

Locations (1)

Hamamatsu University School of Medicine; 🇯🇵 Hamamatsu, Japan