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Varicella Vaccination With Pulmicort

Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: budesonide (Drug); varicella zoster virus (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Bertill Andersson, Study Director, Affiliation: AstraZeneca employee

Summary

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

Clinical Details

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

Primary outcome: Seroconversion level

Eligibility

Minimum age: 10 Months. Maximum age: 8 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: October 2001
Ending date: June 2004
Last updated: March 21, 2008

Page last updated: June 20, 2008

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