Official Title: “Rates of Seroconversion Following Varicella Vaccination of Asthmatic Children Between the Ages of One and Eight Years Treated With Pulmicort Respules® Versus Non-Steroidal Conventional Asthma Therapy”

A study to determine whether treatment with Pulmicort in children has any effect on the varicella vaccine

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2003

Intervention(s) in this Clinical Trial

• Drug: budesonide
• Drug: varicella zoster virus

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Pulmicort
• Active Comparator: 2
  • Varivax

Primary Measures

• Seroconversion level
  • Time Frame: Week 6
    

Inclusion Criteria:

• Children between the age of 10 months and 8 years,
• have asthma or shown recent signs suggesting asthma,
• have a parent or guardian willing to comply with study requirements

Exclusion Criteria:

• Varicella zoster immune globulin (VZIG) within 5 months prior to immunization,
• Previous varicella immunization,
• an immunization or allergy immunotherapy 4 weeks prior to immunization,
• Severe asthma,
• have another persistent lung disease,
• have a planned hospitalization for the duration of study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Months

Maximum Age for this Clinical Trial: 8 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Bertill Andersson Study Director AstraZeneca employee  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641446

Study ID Number: SD-004-0758

ClinicalTrials.gov Identifier: NCT00641446

Health Authority: Puerto Rico: Food and Drug Administration