Varicella Vaccination With Pulmicort - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00641446

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: budesonide Drug: varicella zoster virus	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Chickenpox Shingles

Drug Information available for: Budesonide Chickenpox Vaccine

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Seroconversion level [ Time Frame: Week 6 ]

Estimated Enrollment:	250
Study Start Date:	October 2001
Study Completion Date:	October 2003
Primary Completion Date:	October 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Pulmicort	Drug: budesonide Other Name: Pulmicort
Active Comparator: 2 Varivax	Drug: varicella zoster virus Other Name: Varivax

Eligibility

Ages Eligible for Study:	10 Months to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641446

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Bertill Andersson

AstraZeneca employee

More Information

No publications provided

Responsible Party:	Lars-Göran Carlsson
ClinicalTrials.gov Identifier:	NCT00641446 History of Changes
Other Study ID Numbers:	SD-004-0758, D5257C00758
Study First Received:	March 18, 2008
Last Updated:	March 24, 2009
Health Authority:	Puerto Rico: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Children
Asthma
Varivax

varicella
Pulmicort
budesonide

Additional relevant MeSH terms:

Asthma
Chickenpox
Herpes Zoster
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012