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

NCT ID: NCT00627731

Last Updated: 2011-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-10-31

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

mPSL 240 mg per day for 5 days

Group Type ACTIVE_COMPARATOR

methylprednisolone sodium succinate (mPSL)

Intervention Type DRUG

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

2

PSL 40mg per day for 10 days

Group Type EXPERIMENTAL

prednisolone (PSL)

Intervention Type DRUG

PSL 40 mg per day for 10 days

Interventions

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methylprednisolone sodium succinate (mPSL)

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

Intervention Type DRUG

prednisolone (PSL)

PSL 40 mg per day for 10 days

Intervention Type DRUG

Other Intervention Names

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methlyprednisolone sodium succinate prednisolone

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamamatsu University

OTHER

Sponsor Role lead

Responsible Party

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Naoki Inui

Department of Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kingo Chida, MD,PhD

Role: STUDY_CHAIR

Hamamatsu University

Locations

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Hamamatsu University School of Medicine

Hamamatsu, , Japan

Site Status

Countries

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Japan

Other Identifiers

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Hamamatsu-1968

Identifier Type: -

Identifier Source: secondary_id

Hamamatsu-18-68

Identifier Type: -

Identifier Source: org_study_id

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