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

September 5, 2011 updated by: Naoki Inui, Hamamatsu University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hamamatsu, Japan
        • Hamamatsu University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of oral prednisolone for the treatment of acute asthma
Time Frame: three-year
three-year

Secondary Outcome Measures

Outcome Measure
Time Frame
The safety of oral prednisolone for the treatment of acute asthma
Time Frame: three-year
three-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamamatsu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

February 22, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (ESTIMATE)

March 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 5, 2011

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hamamatsu-18-68
  • Hamamatsu-1968

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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