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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naoki Inui, Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00627731
First received: February 22, 2008
Last updated: September 5, 2011
Last verified: October 2009
  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: methylprednisolone sodium succinate (mPSL)
Drug: prednisolone (PSL)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 50
Study Start Date: June 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Locations
Japan
Hamamatsu University School of Medicine
Hamamatsu, Japan
Sponsors and Collaborators
Hamamatsu University
Investigators
Study Chair: Kingo Chida, MD,PhD Hamamatsu University
  More Information

No publications provided

Responsible Party: Naoki Inui, Department of Respiratory Medicine, Hamamatsu University
ClinicalTrials.gov Identifier: NCT00627731     History of Changes
Other Study ID Numbers: Hamamatsu-18-68, Hamamatsu-1968
Study First Received: February 22, 2008
Last Updated: September 5, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Hamamatsu University:
Asthma Patients

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014