AsthmaPhase 4NCT00641446
Varicella Vaccination With Pulmicort
A Phase 4 study testing budesonide and varicella zoster virus in people with Asthma, run by AstraZeneca.
Trial summary
A study to determine whether treatment with Pulmicort in children has any effect on the varicella vaccine Read more about this study
- Who is it for?
- Ages 10 months to 8 years
- Conditions the study is for
- Asthma
- What is being tested?
- budesonide and varicella zoster virus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Oct 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
- Conditions
- Asthma
- Being tested
- budesonide, varicella zoster virus
- Keywords
- Children, Asthma, Varivax, varicella, Pulmicort, budesonide
- Medical subject headings
- Asthma, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
Also called Pulmicort
varicella zoster virusDrug
Also called Varivax
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pulmicort Receives: Drug: budesonide |
| 2 | Active comparator | Varivax Receives: Drug: varicella zoster virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion level
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startOct 2001
- Primary completionOct 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bertill Andersson, Study director, AstraZeneca employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641446
- Sponsor's protocol ID
- SD-004-0758
- Other IDs
- D5257C00758
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2008
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00641446
- Acronym / sponsor ID
- SD-004-0758
- Conditions
- Asthma
- Keywords
- Children, Asthma, Varivax, varicella, Pulmicort, budesonide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to determine whether treatment with Pulmicort in children has any effect on the varicella vaccine
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: budesonidePulmicort |
| 2 | Active comparator | Drug: varicella zoster virusVarivax |
Who may qualify
- Ages
- 10 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budesonideAlso: Pulmicort | Drug | 1 |
| varicella zoster virusAlso: Varivax | Drug | 2 |
Primary outcome
Seroconversion level
Time frame: Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertill Andersson study director
AstraZeneca employee
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing budesonide and varicella zoster virus in people with Asthma, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion level (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2009.