NCT00627731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Jun 2007

Typical duration for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

September 7, 2011

Status Verified

October 1, 2009

Enrollment Period

2.3 years

First QC Date

February 22, 2008

Last Update Submit

September 5, 2011

Conditions

Asthma

Keywords

Asthma Patients

Outcome Measures

Primary Outcomes (1)

  • Efficacy of oral prednisolone for the treatment of acute asthma

    three-year

Secondary Outcomes (1)

  • The safety of oral prednisolone for the treatment of acute asthma

    three-year

Study Arms (2)

1

ACTIVE COMPARATOR

mPSL 240 mg per day for 5 days

Drug: methylprednisolone sodium succinate (mPSL)

2

EXPERIMENTAL

PSL 40mg per day for 10 days

Drug: prednisolone (PSL)

Interventions

methylprednisolone sodium succinate (mPSL)DRUG

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

Also known as: methlyprednisolone sodium succinate
1
prednisolone (PSL)DRUG

PSL 40 mg per day for 10 days

Also known as: prednisolone
2

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

Methylprednisolone HemisuccinatePrednisolone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

MethylprednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kingo Chida, MD,PhD

    Hamamatsu University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Respiratory Medicine

Study Record Dates

First Submitted

February 22, 2008

First Posted

March 3, 2008

Study Start

June 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

September 7, 2011

Record last verified: 2009-10

Locations

JP(1)