NCT00641446

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4 asthma

Timeline
Completed

Started Oct 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

2 years

First QC Date

March 18, 2008

Last Update Submit

March 24, 2009

Conditions

Asthma

Keywords

ChildrenAsthmaVarivaxvaricellaPulmicortbudesonide

Outcome Measures

Primary Outcomes (1)

  • Seroconversion level

    Week 6

Study Arms (2)

1

EXPERIMENTAL

Pulmicort

Drug: budesonide

2

ACTIVE COMPARATOR

Varivax

Drug: varicella zoster virus

Interventions

budesonideDRUG
Also known as: Pulmicort
1
varicella zoster virusDRUG
Also known as: Varivax
2

Eligibility Criteria

Age10 Months - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaChickenpox

Interventions

BudesonideChickenpox Vaccine

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Bertill Andersson

    AstraZeneca employee

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 24, 2008

Study Start

October 1, 2001

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

March 25, 2009

Record last verified: 2009-03