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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00627731
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : September 7, 2011
Information provided by (Responsible Party):
Naoki Inui, Hamamatsu University

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: methylprednisolone sodium succinate (mPSL) Drug: prednisolone (PSL) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients
Study Start Date : June 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Active Comparator: 1
mPSL 240 mg per day for 5 days
Drug: methylprednisolone sodium succinate (mPSL)
mPSL IV 240mg per day for 5 days and oral PSL 40mg per day for 5 days
Other Name: methlyprednisolone sodium succinate

Experimental: 2
PSL 40mg per day for 10 days
Drug: prednisolone (PSL)
PSL 40 mg per day for 10 days
Other Name: prednisolone

Primary Outcome Measures :
  1. Efficacy of oral prednisolone for the treatment of acute asthma [ Time Frame: three-year ]

Secondary Outcome Measures :
  1. The safety of oral prednisolone for the treatment of acute asthma [ Time Frame: three-year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00627731

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Hamamatsu University School of Medicine
Hamamatsu, Japan
Sponsors and Collaborators
Hamamatsu University
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Study Chair: Kingo Chida, MD,PhD Hamamatsu University
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Responsible Party: Naoki Inui, Department of Respiratory Medicine, Hamamatsu University Identifier: NCT00627731    
Other Study ID Numbers: Hamamatsu-18-68
First Posted: March 3, 2008    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: October 2009
Keywords provided by Naoki Inui, Hamamatsu University:
Asthma Patients
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents