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

Sponsor
Hamamatsu University (Other)
Overall Status
Completed
CT.gov ID
NCT00627731
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
28
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: methylprednisolone sodium succinate (mPSL)
  • Drug: prednisolone (PSL)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

mPSL 240 mg per day for 5 days

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

    		•
    Experimental: 2

    PSL 40mg per day for 10 days

    Drug: prednisolone (PSL)
    PSL 40 mg per day for 10 days
    Other Names:
  • prednisolone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of oral prednisolone for the treatment of acute asthma [three-year]

    Secondary Outcome Measures

    1. The safety of oral prednisolone for the treatment of acute asthma [three-year]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Hamamatsu University

    Investigators

    • Study Chair: Kingo Chida, MD,PhD, Hamamatsu University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Naoki Inui, Department of Respiratory Medicine, Hamamatsu University
    ClinicalTrials.gov Identifier:
    NCT00627731
    Other Study ID Numbers:
    • Hamamatsu-18-68
    • Hamamatsu-1968
    First Posted:
    Mar 3, 2008
    Last Update Posted:
    Sep 7, 2011
    Last Verified:
    Oct 1, 2009
    Keywords provided by Naoki Inui, Department of Respiratory Medicine, Hamamatsu University
    Asthma Patients
    Additional relevant MeSH terms:
    Asthma
    Methylprednisolone
    Methylprednisolone Acetate
    Methylprednisolone Hemisuccinate
    Prednisolone
    Prednisolone acetate
    Prednisolone hemisuccinate
    Prednisolone phosphate

    Study Results

    No Results Posted as of Sep 7, 2011