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

Hamamatsu University

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: methylprednisolone sodium succinate (mPSL); Drug: prednisolone (PSL)

Study type: Interventional

Funder types: Other

Identifiers

NCT00627731

Hamamatsu-1968

Hamamatsu-18-68

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Active Comparator group

Description:

mPSL 240 mg per day for 5 days

Treatment:

Drug: methylprednisolone sodium succinate (mPSL)

2

Experimental group

Description:

PSL 40mg per day for 10 days

Treatment:

Drug: prednisolone (PSL)