Preventing Asthma in High Risk Kids (PARK)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02570984 |
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Recruitment Status :
Recruiting
First Posted : October 8, 2015
Last Update Posted : February 8, 2023
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Sponsor:
Boston Children's Hospital
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Wanda Phipatanakul, Boston Children's Hospital
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Brief 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 active asthma in the Final 12 months during 2 year observation period off study drug.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Drug: Omalizumab Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Controlling and Preventing Asthma Progression and Severity in Kids |
| Actual Study Start Date : | November 27, 2018 |
| Estimated Primary Completion Date : | November 27, 2025 |
| Estimated Study Completion Date : | November 27, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Asthma
Drug Information available for:
Omalizumab
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Active
omalizumab 0.016 mg/kg/IU total IgE
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Drug: Omalizumab
anti-ige injection
Other Name: Xolair |
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Placebo Comparator: Placebo
looks like active drug
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Drug: Placebo
placebo comparator arm, injection similar to active
Other Name: placebo arm |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- number of positive new allergic sensitization [ Time Frame: Final 12 months during 2 year observation period off study drug ]skin prick test
- decrease in number of wheezing episodes [ Time Frame: Final 12 months during 2 year observation period off study drug ]questionnaires
Information from the National Library of Medicine
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| Ages Eligible for Study: | 24 Months to 47 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- >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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570984
Contacts
| Contact: Wanda Phipatanakul, MD, MS | 857-218-5336 | wanda.phipatanakul@childrens.harvard.edu | |
| Contact: Gabriel Federo, MD, MPH | 857-218-5336 | asthma@childrens.harvard.edu |
Locations
| United States, Arizona | |
| Phoenix Children's Hospital | Recruiting |
| Phoenix, Arizona, United States, 85016 | |
| Contact: Cindy Bauer, MD. 602-933-3666 cbauer@phoenixchildrens.com | |
| Contact: Songhee Han 602-933-5067 shan@phoenixchildrens.com | |
| Principal Investigator: Cindy Bauer, MD. | |
| United States, California | |
| Rady Children's Hospital - San Diego | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Diba Mortazavi 858-966-1700 ext 3422 dmortazavi@ucsd.edu | |
| Principal Investigator: Sydney Leibel, MD. | |
| United States, Colorado | |
| Childrens Hospital Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Childrens H Colorado | |
| Contact: Megan Bandeira 720-777-6860 Megan.Bandeira@childrenscolorado.org | |
| Principal Investigator: Andrew Liu, MD | |
| United States, Connecticut | |
| Connecticut Children's Hospital | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Masai McIntosh, MD 860-837-7568 mmcintosh@connecticutchildrens.org | |
| Principal Investigator: Craig Lapin, MD | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Alicia Mathis 202-476-4698 ANewcome@childrensnational.org | |
| Principal Investigator: Stephen Teach, MD. MPH. | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Morgan Nicholls, PhD, NP 404-785-2958 morgan.nicholls@choa.org | |
| Principal Investigator: Anne Fitzpatrick, PhD, NP. | |
| United States, Illinois | |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Melanie M. Makhija, MD. MS 312-227-6010 mmakhija@luriechildrens.org | |
| Contact: Michelle Catalano, BS,LPN,CCRP (312) 227-6455 MCatalano@luriechildrens.org | |
| Principal Investigator: Melanie Makhija, MD.MS. | |
| United States, Indiana | |
| Indiana University/Riley Children's Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Lori Shively, RN, CCRC 317-278-7121 lashivel@iu.edu | |
| Principal Investigator: Kirsten Kloepfer, MD | |
| United States, Massachusetts | |
| Boston Children's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Gabriel Federo, MD. 857-218-5336 gabriel.federohungria@childrens.harvard.edu | |
| Principal Investigator: Wanda Phipatanakul, MD. MSc. | |
| United States, Missouri | |
| Washington University | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Tina Norris, CRTT 314-368-0208 norris.t@wustl.edu | |
| Principal Investigator: Jeffrey Stokes, MD | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Emily Capal, BS 513-636-7886 Emily.Capal@cchmc.org | |
| Principal Investigator: Theresa Guilbert, MD. | |
| United States, Texas | |
| Texas Children's Hospital/Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Daisy Tran 832-824-3640 Dxtran1@texaschildrens.org | |
| Principal Investigator: Carla Davis, MD | |
| United States, Wisconsin | |
| University of Wisconsin | Recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Contact: Michelle Olson 608-263-3360 mrolson@medicine.wisc.edu | |
| Principal Investigator: Daniel Jackson, MD | |
Sponsors and Collaborators
Boston Children's Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
| Principal Investigator: | Wanda Phipatanakul, MD, MS | Boston Children's Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wanda Phipatanakul, Professor of Pediatrics, Boston Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT02570984 |
| Other Study ID Numbers: |
IRB-P00019640 |
| First Posted: | October 8, 2015 Key Record Dates |
| Last Update Posted: | February 8, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Omalizumab Anti-Allergic Agents Anti-Asthmatic Agents Respiratory System Agents |