Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents (NCT05347771) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents
United States240 participantsStarted 2022-05-04
Plain-language summary
This is a multi-center, double-blind, placebo-controlled, randomized trial of dupilumab adjunctive therapy for prevention of asthma exacerbations in urban children and adolescents with T2-high exacerbation-prone asthma.
Who can participate
Age range6 Years – 17 Years
SexALL
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Inclusion criteria
✓. Participant and/or parent guardian must be able to understand and provide informed consent and age-appropriate assent
✓. Are male and female aged 6-17 years at Visit 0
✓. 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.
✓. 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.
✓. Participant has had at least two asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization).
✓. At Visit 0 (screening), participant must have the following requirement for asthma controller medication:
✓. Participants aged 6 to 11 years: treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent.
✓. 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.
Exclusion criteria
✕. Parent or guardian is not able or willing to give written informed consent or comply with study protocol.
What they're measuring
1
Number of asthma exacerbations during the 12-month treatment period
✕. Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study.
✕. Are currently receiving immunotherapy.
✕. Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to randomization.
✕. 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.
✕. 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.
✕. Have a known, pre-existing clinically important lung condition other than asthma.
✕. Have a current malignancy or previous history of cancer in remission for less than 12 months prior to randomization.