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Completed

NCT Number: NCT00627731

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hamamatsu University School of Medicine

Hamamatsu, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone sodium succinate (mPSL)

Drug

mPSL IV 240mg per day for 5 days and oral PSL 40mg per day for 5 days

Other names: methlyprednisolone sodium succinate

prednisolone (PSL)

Drug

PSL 40 mg per day for 10 days

Other names: prednisolone

Primary outcomes

  1. Efficacy of oral prednisolone for the treatment of acute asthma

    Time frame: three-year

Secondary outcomes

  1. The safety of oral prednisolone for the treatment of acute asthma

    Time frame: three-year

Sponsors and collaborators

Lead sponsor

Hamamatsu University

Other

Registry information

Official study title

Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 3, 2008
Registry last updated
Sep 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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