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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI179563 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
Prevention/ Disease modification of asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | omalizumab 0.016 mg/kg/IU total IgE |
|
| Placebo | Placebo Comparator | looks like active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug | anti-ige injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| active asthma diagnosis | questionnaire | Final 12 months during 2 year observation period off study drug |
| asthma severity | questionnaire | Final 12 months during 2 year observation period off study drug |
| Measure | Description | Time Frame |
|---|---|---|
| number of positive new allergic sensitization | skin prick test | Final 12 months during 2 year observation period off study drug |
| decrease in number of wheezing episodes | questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wanda Phipatanakul, MD, MS | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Rady Children's Hospital - San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33242697 | Derived | 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. | |
| 30954166 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Placebo |
| Drug |
placebo comparator arm, injection similar to active |
|
|
| Final 12 months during 2 year observation period off study drug |
| San Diego |
| California |
| 92123 |
| United States |
| Childrens Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Connecticut Children's Hospital | Hartford | Connecticut | 06106 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Indiana University/Riley Children's Hospital | Indianapolis | Indiana | 46202 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Texas Children's Hospital/Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Derived |
| Martinez 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. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |