Oral Glucocorticosteroid in the Treatment of Severe Asthma Exacerbation in Hospitalized Patients - Full Text View

Sponsored by:	Hamamatsu University
Information provided by:	Hamamatsu University
ClinicalTrials.gov Identifier:	NCT00627731

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: methlypredonisolone sodium succinate (mPSL) Drug: predonisolone (PSL)	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Succinic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients

Further study details as provided by Hamamatsu University:

Primary Outcome Measures:

Efficacy of oral prednisolone for the treatment of acute asthma [ Time Frame: three-year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The safety of oral prednisolone for the treatment of acute asthma [ Time Frame: three-year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	June 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator mPSL 240 mg per day for 5 days	Drug: methlypredonisolone sodium succinate (mPSL) mPSL IV 240mg per day for 5 days and oral PSL 40mg per day for 5 days
2: Experimental PSL 40mg per day for 10 days	Drug: predonisolone (PSL) PSL 40 mg per day for 10 days

Eligibility

Ages Eligible for Study:	16 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627731

Contacts

Contact: Naoki Inui, MD,PhD

81-53-435-2385

may15@hama-med.ac.jp

Locations

Japan
Hamamatsu University School of Medicine	Recruiting
Hamamatsu, Japan
Contact: Naoki Inui, MD,PhD 81-53-435-2385 may15@hama-med.ac.jp
Principal Investigator: Yutaka Nakano, MD,PhD

Sponsors and Collaborators

Hamamatsu University

Investigators

Study Chair:

Kingo Chida, MD,PhD

Hamamatsu University

More Information

Responsible Party:	Hamamatsu University School of Medicine, Respiratory Medicine ( Hamamatsu University School of Medicine, Respiratory Medicine )
Study ID Numbers:	Hamamatsu-18-68, Hamamatsu-1968
Study First Received:	February 22, 2008
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00627731
Health Authority:	Japan: Institutional Review Board

Keywords provided by Hamamatsu University:

Asthma Patients

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Status Asthmaticus
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009