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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
History of Changes
  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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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
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
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
 Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013