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CompletedNCT00627731Updated Sep 7, 2011

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

A Phase 4 interventional study of methylprednisolone sodium succinate (mPSL) and prednisolone (PSL) in Asthma, sponsored by Hamamatsu University. Completed at 1 site in Japan. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-09-07.

Sponsored by Hamamatsu University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
16 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma Patients
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 50 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Hamamatsu University is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
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

Exclusion Criteria:

  • Need for incubation
  • With severe complications
  • Received systemic glucocorticosteroid therapy in the previous 4 weeks
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    1

    mPSL 240 mg per day for 5 days

    Drug: methylprednisolone sodium succinate (mPSL)

  • Experimental
    2

    PSL 40mg per day for 10 days

    Drug: prednisolone (PSL)

Interventions

  • Drugmethylprednisolone sodium succinate (mPSL)

    mPSL IV 240mg per day for 5 days and oral PSL 40mg per day for 5 days

    Also known as: methlyprednisolone sodium succinate

  • Drugprednisolone (PSL)

    PSL 40 mg per day for 10 days

    Also known as: prednisolone

06

What researchers measure

Primary outcomes

  1. Efficacy of oral prednisolone for the treatment of acute asthma

    Time frame: three-year

Secondary outcomes

  1. The safety of oral prednisolone for the treatment of acute asthma

    Time frame: three-year

07

Study locations

1 site
  • Hamamatsu University School of Medicine
    Hamamatsu, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00627731
Lead sponsor
Hamamatsu University
Responsible party
Naoki Inui (Department of Respiratory Medicine, Hamamatsu University) — Principal investigator
First posted
Mar 3, 2008
Start date
Jun 2007
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Sep 7, 2011

Study contacts

Kingo Chida, MD,PhD
study chair · Hamamatsu University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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