AsthmaPhase 4NCT00624429
A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children
A Phase 4 study testing Budesonide respules in people with Asthma, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
The Early Head Start program serves lower socioeconomic inner-city children from birth to 3 years. This population has a higher incidence of asthma due to increased exposures. The primary objective of this study is: To evaluate the effect of early identification of these high risk, inner-city asthmatic infants, age… Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide respules
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2010
- 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 12 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 12-36 months of age with a history of wheezing or airway reactivity responding to bronchodilators, or diagnosed with asthma by a physician.
Who cannot join
- Children less than 12 months or greater than 36 months of age.
- Children diagnosed with attention deficit disorder by a physician or psychologist.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Peggy Radford, MD, 602-546-0985, pradfor@phoenixchildrens.com
Peggy Radford, MD
About this study
The Early Head Start program serves lower socioeconomic inner-city children from birth to 3 years. This population has a higher incidence of asthma due to increased exposures. The primary objective of this study is:
To evaluate the effect of early identification of these high risk, inner-city asthmatic infants, age 1-3 years, and early treatment with pulmicort respules on asthma morbidity (asthma symptoms and use of rescue medications), infant pulmonary functions, and use of health care resources (unscheduled clinic visits, emergency room visits and hospitalizations).
To obtain pilot behavior information using Carey Temperament Scale, Bitsea and expand to Itsea if indicated.
- Conditions
- Asthma
- Being tested
- Budesonide respules
- Keywords
- Asthma, Children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide respulesDrug
Also called Pulmicort respules
Budesonide respules 0.5 mg nebulized once a day for 4 months of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV0.5
Measured: 2 months and 6 months into study
Secondary outcomes (3)
emergency room visits
Measured: number of visits from baseline to 2 months and 2 months to 6months of study
behavior scores
Measured: measured at baseline, 2 months and 6 months
number of asthma exacerbations from baseline to 2 months and 2 months to 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009 (estimated)
- Study completionJan 2010 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Peggy Radford, MD, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624429
- Sponsor's protocol ID
- 07-053
- Status last verified
- Feb 2009
- First submitted
- 15 Feb 2008
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children
- ClinicalTrials.gov ID
- NCT00624429
- Acronym / sponsor ID
- 07-053
- Conditions
- Asthma
- Keywords
- Asthma, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 27 Feb 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.
The Early Head Start program serves lower socioeconomic inner-city children from birth to 3 years. This population has a higher incidence of asthma due to increased exposures. The primary objective of this study is:
To evaluate the effect of early identification of these high risk, inner-city asthmatic infants, age 1-3 years, and early treatment with pulmicort respules on asthma morbidity (asthma symptoms and use of rescue medications), infant pulmonary functions, and use of health care resources (unscheduled clinic visits, emergency room visits and hospitalizations).
To obtain pilot behavior information using Carey Temperament Scale, Bitsea and expand to Itsea if indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 12-36 months of age with a history of wheezing or airway reactivity responding to bronchodilators, or diagnosed with asthma by a physician.
Key exclusion criteria (2 listed)
- Children less than 12 months or greater than 36 months of age.
- Children diagnosed with attention deficit disorder by a physician or psychologist.
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 |
|---|---|---|
| Budesonide respulesAlso: Pulmicort respulesBudesonide respules 0.5 mg nebulized once a day for 4 months of the study. | Drug | – |
Primary outcome
FEV0.5
Time frame: 2 months and 6 months into study
3 secondary outcomes
emergency room visits
Time frame: number of visits from baseline to 2 months and 2 months to 6months of study
behavior scores
Time frame: measured at baseline, 2 months and 6 months
number of asthma exacerbations from baseline to 2 months and 2 months to 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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.
Peggy Radford, MD principal investigator
Phoenix Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide respules in people with Asthma, run by Phoenix Children's Hospital at 1 site in United States.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Sep 2009. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peggy Radford, MD (602-546-0985, pradfor@phoenixchildrens.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV0.5 (time frame: 2 months and 6 months into study). 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 18 Sep 2009.