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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00627731
First Posted: March 3, 2008
Last Update Posted: September 7, 2011
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.
Information provided by (Responsible Party):
Naoki Inui, Hamamatsu University
  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
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

Resource links provided by NLM:


Further study details as provided by Naoki Inui, Hamamatsu University:

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 22, 2008
First Posted: March 3, 2008
Last Update Posted: September 7, 2011
Last Verified: October 2009

Keywords provided by Naoki Inui, 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
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents