AsthmaPhase 2PARKNCT02570984
Preventing Asthma in High Risk Kids
A Phase 2 study testing Omalizumab in people with Asthma, run by Boston Children's Hospital at 13 sites in United States.
Trial summary
This trial is a randomized, double-blind, placebo controlled trial designed to test whether two years treatment of preschool children aged 2-3 years of age at high risk for asthma with omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as reflected by a reduction in the prevalence of… Read more about this study
- Who is it for?
- Ages 24 to 47 months
- Conditions the study is for
- Asthma
- What is being tested?
- Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 13 sitesUnited States
- Study dates
- 27 Nov 2018to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 24 to 47 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent/guardian must be able to understand and provide signed and dated written informed consent; he/she must also be able to communicate with study staff.
- 24-47 months of age at randomization
- 2-4 wheezing episodes in the past year
- positive allergy to aeroallergen
- first degree relative with history or current diagnosis of asthma or allergy
- If is participating in a food immunotherapy treatment that is not part of a clinical trial, has been on an established maintenance regimen implemented continuously for a minimum of 2 months.
Who cannot join
- >4 episodes of wheezing in the past year
- Use of Step 5 or Step 6 therapy (ICS plus LABA ) at the time of enrollment (Visit 0).
- Need for systemic corticosteroids or a hospitalization for respiratory symptoms within four weeks prior to screening.
- Three or more courses of systemic corticosteroids for wheezing illnesses in the last year
- More than four days of symptoms of wheezing, or tightness in the chest or cough in the past two weeks causing at least minimal limitation of activity
- More than four days of albuterol treatment (for symptoms) in the past two weeks
Show all 22Show fewer
- More than one night of symptoms of wheezing, or tightness in the chest or cough causing sleep disruption in the past two weeks
- More than one night of albuterol treatment (for symptoms) in the past two weeks
- Prematurity (<34 weeks gestation)
- Need for oxygen for more than 5 days in the neonatal period
- History of intubation or mechanical ventilation for respiratory illness
- Other significant medical conditions, including: major congenital anomalies, cystic fibrosis, chronic pulmonary diseases, bronchopulmonary dysplasia, thoracic surgery, history of tuberculosis, immunodeficiency (primary or secondary), seizure disorders
- Expecting to relocate within 4 years of study initiation to a place which would make in-person clinical visits impossible
- Deemed unable to adhere to study activities
- Prior aeroallergen immunotherapy or use of biologics including anti-IgE
- Prior IVIG or systemic immunosuppressant other than corticosteroids
- History of hypoxic seizures during a wheezing episode
- Total IgE outside of the omalizumab dosing range.
- Enrolled in any clinical medication trial within the past 30 days.
- With platelet counts < 150 x 109/L at the Screening Visit (V0)
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study.
- History of severe anaphylactic/anaphylactoid reactions from any cause
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Emory University
Atlanta, Georgia, 30322
Childrens Hospital Colorado
Aurora, Colorado, 80045
Boston Children's Hospital
Boston, Massachusetts, 02115
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Connecticut Children's Hospital
Hartford, Connecticut, 06106
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77030
Indiana University/Riley Children's Hospital
Indianapolis, Indiana, 46202
University of Wisconsin
Madison, Wisconsin, 53792
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Rady Children's Hospital - San Diego
San Diego, California, 92123
Washington University
St Louis, Missouri, 63110
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Controlling and Preventing Asthma Progression and Severity in Kids
This trial is a randomized, double-blind, placebo controlled trial designed to test whether two years treatment of preschool children aged 2-3 years of age at high risk for asthma with omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2 year observation period off study drug.
Read the detailed description
Prevention/ Disease modification of asthma.
- Conditions
- Asthma
- Being tested
- Omalizumab, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called Xolair
anti-ige injection
PlaceboDrug
Also called placebo arm
placebo comparator arm, injection similar to active
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | omalizumab 0.016 mg/kg/IU total IgE Receives: Drug: Omalizumab |
| Placebo | Placebo comparator | looks like active drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
active asthma diagnosis
questionnaire
Measured: Final 12 months during 2 year observation period off study drug
asthma severity
questionnaire
Measured: Final 12 months during 2 year observation period off study drug
Secondary outcomes (2)
number of positive new allergic sensitization
skin prick test
Measured: Final 12 months during 2 year observation period off study drug
decrease in number of wheezing episodes
questionnaires
Measured: Final 12 months during 2 year observation period off study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start27 Nov 2018
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanda Phipatanakul, Harvard Medical School (HMS and HSDM)
- Investigators
- Wanda Phipatanakul, MD, MS, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570984
- Sponsor's protocol ID
- IRB-P00019640
- Other IDs
- U01AI179563
- Acronym
- PARK
- Status last verified
- Dec 2025
- First submitted
- 28 Jul 2015
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Phipatanakul W, Mauger DT, Guilbert TW, Bacharier LB, Durrani S, Jackson DJ, Martinez FD, Fitzpatrick AM, Cunningham A, Kunselman S, Wheatley LM, Bauer C, Davis CM, Geng B, Kloepfer KM, Lapin C, Liu AH, Pongracic JA, Teach SJ, Chmiel J, Gaffin JM, Greenhawt M, Gupta MR, Lai PS, Lemanske RF, Morgan WJ, Sheehan WJ, Stokes J, Thorne PS, Oettgen HC, Israel E; PARK Study Team. Preventing asthma in high risk kids (PARK) with omalizumab: Design, rationale, methods, lessons learned and adaptation. Contemp Clin Trials. 2021 Jan;100:106228. doi: 10.1016/j.cct.2020.106228. Epub 2020 Nov 24.
PubMed 33242697Martinez FD. Childhood Asthma Inception and Progression: Role of Microbial Exposures, Susceptibility to Viruses and Early Allergic Sensitization. Immunol Allergy Clin North Am. 2019 May;39(2):141-150. doi: 10.1016/j.iac.2018.12.001.
PubMed 30954166
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling and Preventing Asthma Progression and Severity in Kids
- ClinicalTrials.gov ID
- NCT02570984
- Acronym / sponsor ID
- PARK / IRB-P00019640
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 8 Oct 2015 (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.
This trial is a randomized, double-blind, placebo controlled trial designed to test whether two years treatment of preschool children aged 2-3 years of age at high risk for asthma with omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2 year observation period off study drug.
Detailed description
Prevention/ Disease modification of asthma.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: Omalizumabomalizumab 0.016 mg/kg/IU total IgE |
| Placebo | Placebo comparator | Drug: Placebolooks like active drug |
Who may qualify
- Ages
- 24 to 47 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parent/guardian must be able to understand and provide signed and dated written informed consent; he/she must also be able to communicate with study staff.
- 24-47 months of age at randomization
- 2-4 wheezing episodes in the past year
- positive allergy to aeroallergen
- first degree relative with history or current diagnosis of asthma or allergy
Key exclusion criteria (22 listed)
- >4 episodes of wheezing in the past year
- Use of Step 5 or Step 6 therapy (ICS plus LABA ) at the time of enrollment (Visit 0).
- Need for systemic corticosteroids or a hospitalization for respiratory symptoms within four weeks prior to screening.
- Three or more courses of systemic corticosteroids for wheezing illnesses in the last year
- More than four days of symptoms of wheezing, or tightness in the chest or cough in the past two weeks causing at least minimal limitation of activity
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 |
|---|---|---|
| OmalizumabAlso: Xolairanti-ige injection | Drug | Active |
| PlaceboAlso: placebo armplacebo comparator arm, injection similar to active | Drug | Placebo |
Primary outcome
active asthma diagnosis
Time frame: Final 12 months during 2 year observation period off study drug
questionnaire
asthma severity
Time frame: Final 12 months during 2 year observation period off study drug
questionnaire
2 secondary outcomes
number of positive new allergic sensitization
Time frame: Final 12 months during 2 year observation period off study drug
decrease in number of wheezing episodes
Time frame: Final 12 months during 2 year observation period off study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Derived from this study: PubMed 33242697Phipatanakul W, Mauger DT, Guilbert TW, Bacharier LB, Durrani S, Jackson DJ, Martinez FD, Fitzpatrick AM, Cunningham A, Kunselman S, Wheatley LM, Bauer C, Davis CM, Geng B, Kloepfer KM, Lapin C, Liu AH, Pongracic JA, Teach SJ, Chmiel J, Gaffin JM, Greenhawt M, Gupta MR, Lai PS, Lemanske RF, Morgan WJ, Sheehan WJ, Stokes J, Thorne PS, Oettgen HC, Israel E; PARK Study Team. Preventing asthma in high risk kids (PARK) with omalizumab: Design, rationale, methods, lessons learned and adaptation. Contemp Clin Trials. 2021 Jan;100:106228. doi: 10.1016/j.cct.2020.106228. Epub 2020 Nov 24.
- Derived from this study: PubMed 30954166Martinez FD. Childhood Asthma Inception and Progression: Role of Microbial Exposures, Susceptibility to Viruses and Early Allergic Sensitization. Immunol Allergy Clin North Am. 2019 May;39(2):141-150. doi: 10.1016/j.iac.2018.12.001.
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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.
Wanda Phipatanakul, MD, MS principal investigator
Boston Children's Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omalizumab in people with Asthma, run by Boston Children's Hospital at 13 sites 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 6 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
active asthma diagnosis (time frame: Final 12 months during 2 year observation period off study drug). The study lists 2 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 NCT02570984, which also lists 2 linked publications.
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 4 Dec 2025.