Oral Glucocorticosteroid in the Treatment of Severe Asthm... | NCT00627731

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

NCT00627731

Sponsor

Hamamatsu University

Status

Completed

Last Update Posted

Sep 7, 2011Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Asthma

Interventions

methylprednisolone sodium succinate (mPSL)
prednisolone (PSL)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Hamamatsu-1968

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Feb 22, 2008

First Submission Date that Met QC Criteria

Feb 29, 2008

First Posted Date

Mar 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2011

Last Update Posted Date

Sep 7, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
methylprednisolone sodium succinate (mPSL)	Drug	mPSL IV 240mg per day for 5 days and oral PSL 40mg per day for 5 days	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kingo Chida, MD,PhD	Hamamatsu University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamamatsu University School of Medicine		Hamamatsu			Japan

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008776	Methylprednisolone Hemisuccinate
D011239	Prednisolone

Ancestor Terms

ID	Term
D008775	Methylprednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes

Browse Leaves

Not provided

Browse Branches

Not provided