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Clinical Trials/EUCTR2004-005124-40-GB
EUCTR2004-005124-40-GB
Active, not recruiting
Phase 1

Efficacy of a short course of oral steroids for hospitalised preschool children with viral-induced wheeze; a randomised double-blind placebo-controlled trial

niversity Hospital Leicester R&D0 sites700 target enrollmentMarch 4, 2005

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Pre School Viral Wheeze
Sponsor
niversity Hospital Leicester R&D
Enrollment
700
Status
Active, not recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 4, 2005
End Date
July 27, 2007
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
niversity Hospital Leicester R&D

Eligibility Criteria

Inclusion Criteria

  • 1\. Children aged 10 months to 60 months (5 years 0 months).
  • 2\. Preceding history of a viral illness with upper respiratory tract symptoms/signs associated with an acute episode of physician diagnosed wheeze (Pre school viral wheeze).
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) no
  • F.1\.2\.1 Number of subjects for this age range
  • F.1\.3 Elderly (\>\=65 years) no
  • F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • 1\. Shock requiring fluid resuscitation (more than 10ml/kg)
  • 2\. Signs of disseminated disease such as meningism.
  • 3\. Cystic fibrosis
  • 4\. Clinical signs suggestive of bronchiolitis.
  • 5\. Diagnosis of immune deficiency.

Outcomes

Primary Outcomes

Not specified

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