AsthmaNCT00626808

A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children

An observational study of Asthma and Wheezing, run by MedImmune LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a retrospective cohort study of children included in a large medical insurance claims database. Read more about this study

Who is it for?: Any age
Conditions the study is for: Asthma, Wheezing, Immunosuppression
How many people: 321,697 participants
Where: 1 siteUnited States
Study dates: Oct 2007to Mar 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Children < 60 months of age.

Children less than 24 months of age during August through January/February.
Children <24 to 59 months of age during August through January/February, with:
two outpatient claims for asthma, or
one inpatient/emergency room claim for asthma, or
one outpatient claim for asthma and at least one SABA prescription during a defined 12-month period.
Children <24 to 59 months of age during August through January/February, without any claims associated with a diagnosis of asthma, but with at least one dispensing for SABA, as indicated by pharmacy claims during a defined 12-month period.
Children 24 to 59 months of age during August to January/February with evidence of immunosuppression prior to the date of influenza vaccination based on available medical and pharmacy claims.

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Research Triangle Park, North Carolina

Other trials in United States

About this study

Official title: A Post Marketing Evaluation of the Effectiveness of the Risk Minimization Plan For Use of FluMist Among Children Less Than 5 Years of Age

This is a retrospective cohort study of children included in a large medical insurance claims database.

Read the detailed description

To evaluate the rate of FluMist administration compared to other influenza vaccine use in the following pediatric populations:
Children younger than 24 months of age
Children 24-59 months of age with a claim associated with a diagnosis of asthma
Children 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
Children 24-59 months of age with immunosuppression
To describe, in children in the above populations who receive FluMist, the type and number of Emergency Room visits or hospitalizations associated with an insurance claim within 42 days of receiving FluMist
To explore the rationale for FluMist immunization of pediatric populations that are excluded from recommended usage by characterizing the use in these populations

Conditions: Asthma, Wheezing, Immunosuppression
Being tested: No Intervention
Medical subject headings: Asthma, Respiratory Sounds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No InterventionDrug
There were no interventions. No subjects were enrolled in this retrospective database study.

Study groups in NCT00626808
Study group	Role	What they receive
1		Children less than 24 months of age Receives: Drug: No Intervention
2		Children 24 to 59 months of age with a claim associated with a diagnosis of asthma Receives: Drug: No Intervention
3		Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing Receives: Drug: No Intervention
4		Children 24-59 months of age with immunosuppression Receives: Drug: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

FluMist Use in Participants up to 59 Months of Age
Among participants up to 59 months of age who received any flu vaccine, number who received FluMist
Measured: 2009-2010
Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist
Specialty of vaccinating physician who provided FluMist.
Measured: 2009-2010
Vaccinating Physician Specialty: General/Family Practitioner
Specialty of vaccinating physician who provided FluMist
Measured: 2009-2010
Vaccinating Physician Specialty: Other
Specialty of vaccinating physician who provided FluMist
Measured: 2009-2010
Vaccinating Physician Specialty: Unknown
Specialty of vaccinating physician who provided FluMist
Measured: 2009-2010
Geographic Region: Northeastern
Geographic region of parents' residence among participants receiving FluMist
Measured: 2009-2010
Geographic Region: North Central
Geographic region of parents' residence among participants receiving FluMist
Measured: 2009-2010
Geographic Region: Southern
Geographic region of parents' residence among participants receiving FluMist
Measured: 2009-2010
Geographic Region: Western
Geographic region of parents' residence among participants receiving FluMist
Measured: 2009-2010
Number of Outpatient Visits: 0
Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination
Measured: 2009-2010
Number of Outpatient Visits: 1
Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination
Measured: 2009-2010
Number of Outpatient Visits: 2 or More
Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination
Measured: 2009-2010
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0
Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.
Measured: 2009-2010
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1
Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.
Measured: 2009-2010
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More
Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.
Measured: 2009-2010

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Mar 2010

First posted29 Feb 2008 (estimated)
Study startOct 2007
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 321,697 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00626808
Sponsor's protocol ID: MI-MA175
Status last verified: Jul 2014
First submitted: 20 Feb 2008
Last updated: 12 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post Marketing Evaluation of the Effectiveness of the Risk Minimization Plan For Use of FluMist Among Children Less Than 5 Years of Age
ClinicalTrials.gov ID: NCT00626808
Acronym / sponsor ID: MI-MA175
Conditions: Asthma, Wheezing, Immunosuppression
Study type: Observational
Recruitment status: Completed
Enrolment: 321,697 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Collaborators: RTI International
Study start: Oct 2007
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 29 Feb 2008 (estimated)
Results: Posted 12 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a retrospective cohort study of children included in a large medical insurance claims database.

Detailed description

To evaluate the rate of FluMist administration compared to other influenza vaccine use in the following pediatric populations:
Children younger than 24 months of age
Children 24-59 months of age with a claim associated with a diagnosis of asthma
Children 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
Children 24-59 months of age with immunosuppression
To describe, in children in the above populations who receive FluMist, the type and number of Emergency Room visits or hospitalizations associated with an insurance claim within 42 days of receiving FluMist
To explore the rationale for FluMist immunization of pediatric populations that are excluded from recommended usage by characterizing the use in these populations

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
1	–	Drug: No InterventionChildren less than 24 months of age
2	–	Drug: No InterventionChildren 24 to 59 months of age with a claim associated with a diagnosis of asthma
3	–	Drug: No InterventionChildren 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
4	–	Drug: No InterventionChildren 24-59 months of age with immunosuppression

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Children < 60 months of age.

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
No InterventionThere were no interventions. No subjects were enrolled in this retrospective database study.	Drug	1, 2, 3, 4

Primary outcome

FluMist Use in Participants up to 59 Months of Age
Time frame: 2009-2010
Among participants up to 59 months of age who received any flu vaccine, number who received FluMist
Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist
Time frame: 2009-2010
Specialty of vaccinating physician who provided FluMist.
Vaccinating Physician Specialty: General/Family Practitioner
Time frame: 2009-2010
Specialty of vaccinating physician who provided FluMist
Vaccinating Physician Specialty: Other
Time frame: 2009-2010
Specialty of vaccinating physician who provided FluMist
Vaccinating Physician Specialty: Unknown
Time frame: 2009-2010
Specialty of vaccinating physician who provided FluMist
Geographic Region: Northeastern
Time frame: 2009-2010
Geographic region of parents' residence among participants receiving FluMist
Geographic Region: North Central
Time frame: 2009-2010
Geographic region of parents' residence among participants receiving FluMist
Geographic Region: Southern
Time frame: 2009-2010
Geographic region of parents' residence among participants receiving FluMist
Geographic Region: Western
Time frame: 2009-2010
Geographic region of parents' residence among participants receiving FluMist
Number of Outpatient Visits: 0
Time frame: 2009-2010
Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination
Number of Outpatient Visits: 1
Time frame: 2009-2010
Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination
Number of Outpatient Visits: 2 or More
Time frame: 2009-2010
Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0
Time frame: 2009-2010
Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1
Time frame: 2009-2010
Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More
Time frame: 2009-2010
Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.

Results and safety

Results posted to the registry on 12 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants Less Than 24 Months of Age	254,464	254,464
Participants 24-59 Months of Age With Asthma	34,316	34,316
Participants 24-59 Months of Age With Wheezing	30,011	30,011
Participants 24-59 Months of Age With Immunosuppression	2,906	2,906

Primary outcome: FluMist Use in Participants up to 59 Months of Age

Time frame: 2009-2010. Number. Unit: Number of participants

Measure	Participants Less Than 24 Months of Age n = 254464	Participants 24-59 Months of Age With Asthma n = 34316	Participants 24-59 Months of Age With Wheezing n = 30011	Participants 24-59 Months of Age With Immunosuppression n = 2906
Value	775	3457	5821	361

Population analysed: General population of participants aged \< 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.

Primary outcome: Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist

Time frame: 2009-2010. Number. Unit: Number of physicians

Measure	Participants Less Than 24 Months of Age n = 775	Participants 24-59 Months of Age With Asthma n = 3457	Participants 24-59 Months of Age With Wheezing n = 5821	Participants 24-59 Months of Age With Immunosuppression n = 361
Value	553	2782	4704	291

Primary outcome: Vaccinating Physician Specialty: General/Family Practitioner

Time frame: 2009-2010. Number. Unit: Number of physicians

Measure	Participants Less Than 24 Months of Age n = 775	Participants 24-59 Months of Age With Asthma n = 3457	Participants 24-59 Months of Age With Wheezing n = 5821	Participants 24-59 Months of Age With Immunosuppression n = 361
Value	60	140	267	13

Primary outcome: Vaccinating Physician Specialty: Other

Time frame: 2009-2010. Number. Unit: Number of physicians

Measure	Participants Less Than 24 Months of Age n = 775	Participants 24-59 Months of Age With Asthma n = 3457	Participants 24-59 Months of Age With Wheezing n = 5821	Participants 24-59 Months of Age With Immunosuppression n = 361
Value	103	346	581	37

Adverse events

Time frame: 2009-2010. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants Less Than 24 Months of Age	0 of 0	0 of 0	Not reported
Children 24-59 Months With Asthma	0 of 0	0 of 0	Not reported
Participants 24-59 Months of Age With Wheezing	0 of 0	0 of 0	Not reported
Participants 24-59 Months of Age With Immunosuppression	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
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Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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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.

Chris Ambrose, M.D. study director

MedImmune LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and Wheezing, run by MedImmune LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

FluMist Use in Participants up to 59 Months of Age (time frame: 2009-2010). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00626808.

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 12 Aug 2014.