Back to resultsVaricella Vaccination With Pulmicort
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
budesonide
varicella zoster virus
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Children, Asthma, Varivax, varicella, Pulmicort, budesonide
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Pulmicort
Varivax
Outcomes
Primary Outcome Measures
Seroconversion level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00641446
Brief Title
Varicella Vaccination With Pulmicort
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to determine whether treatment with Pulmicort in children has any effect on the varicella vaccine
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Children, Asthma, Varivax, varicella, Pulmicort, budesonide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Pulmicort
Arm Title
2
Arm Type
Active Comparator
Arm Description
Varivax
Intervention Type
Drug
Intervention Name(s)
budesonide
Other Intervention Name(s)
Pulmicort
Intervention Type
Drug
Intervention Name(s)
varicella zoster virus
Other Intervention Name(s)
Varivax
Primary Outcome Measure Information:
Title
Seroconversion level
Time Frame
Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertill Andersson
Organizational Affiliation
AstraZeneca employee
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Varicella Vaccination With Pulmicort
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