Can a shot stop asthma attacks in city kids?
NCT ID NCT05347771
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding dupilumab (Dupixent) to standard asthma care can prevent asthma attacks in 240 urban children and teens aged 6–17 with severe, allergy-driven asthma. Participants receive either dupilumab or a placebo for 12 months. The main goal is to see if the drug reduces the number of asthma attacks that require steroids.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dupilumab (Dupixent)
- What this could lead to
- If it works, this could provide a new way to prevent severe asthma attacks in children and teens living in urban areas.
- What could go wrong
- This is a Phase 2 trial, so it's still early. The drug may not reduce attacks significantly, and side effects like injection reactions or infections are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participant and/or parent guardian must be able to understand and provide informed consent and age-appropriate assent 2. Are male and female aged 6-17 years at Visit 0 3. Participant has a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol CAUSE01 Manual of Operations (MOP). Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion. 4. Participant has a diagnosis of asthma made \> 1 year prior to recruitment. Participants who received an asthma diagnosis by a clinician ≤1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment. 5. Participant has had at least two asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization). 6. At Visit 0 (screening), participant must have the following requirement for asthma controller medication: 1. Participants aged 6 to 11 years: treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent. 2. Participants aged 12 years and older, treatment with at least fluticasone 250 mcg plus long-acting beta agonist (LABA) DPI one puff twice daily or its equivalent. 7. Have peripheral blood eosinophils ≥150 cells/mcl and/or FeNO ≥ 20ppb obtained at Visit 0 or via another CAUSE protocol within 6 months. 8. Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to randomization. 9. Have documentation of current medical insurance with prescription coverage at Visit 0. Exclusion Criteria: 1. Parent or guardian is not able or willing to give written informed consent or comply with study protocol. 2. Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study. 3. Are currently receiving immunotherapy. 4. Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to randomization. 5. Are currently requiring greater than fluticasone 500 mcg bid plus long-acting beta agonist (LABA) one puff twice daily or its equivalent plus Long-acting muscarinic antagonists (LAMA) and/or individuals using oral corticosteroids daily or every other day for more than 14 days at the time of Visit 0. 6. Are currently pregnant or lactating, or plan to become pregnant during the time of study participation. Participants of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (i.e., oral subcutaneous, mechanical, or surgical contraception). Males who are sexually active must agree to use an acceptable method of birth control (i.e., barrier methods with vaginal spermicide) or have a partner practicing an approved birth control method. 7. Have a known, pre-existing clinically important lung condition other than asthma. 8. Have a current malignancy or previous history of cancer in remission for less than 12 months prior to randomization. 9. Is a current smoker or is currently using any electronic cigarette or vaping device (e.g. e-cigarette, e- cig, mod, vape pen, JUUL, e-cigar, e-hookah, e-pipe, vape pods). 10. Have a known immunodeficiency disease. 11. Have a known, active pre-existing parasitic infection or are undergoing treatment for a parasitic infection. Once the participant has been successfully treated, the participant may be reevaluated. 12. Use of investigational drugs within 4 weeks of randomization 13. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 14. Will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who is not willing to change their asthma medications to follow the Protocol CAUSE- 01 PANDA. 15. Have a known history of allergic reaction to dupilumab. 16. Have had a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure. 17. Have received a live (attenuated) vaccine within 4 weeks of Visit 0. 18. Have an eosinophil count of ≥1500 cells/mcl at Visit 0. Potential participants may be reassessed as outlined in the Protocol CAUSE-01 MOP.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology
Chicago, Illinois, 60611, United States
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Boston Children's Hospital: Department of Immunology
Boston, Massachusetts, 02215, United States
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Children's Hospital Colorado: Allergy Program
Aurora, Colorado, 80045, United States
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Children's National Medical Center: Children's Research Institute
Washington D.C., District of Columbia, 20010, United States
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Cincinnati Children's Hospital Medical Center: Asthma Center
Cincinnati, Ohio, 45229, United States
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Columbia University Medical Center: Division of Pediatric Pulmonology
New York, New York, 10032, United States
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Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute
New York, New York, 10029, United States
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Washington University at St. Louis
St Louis, Missouri, 63110, United States
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