ACTIVE_NOT_RECRUITING

Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents (PANDA) (CAUSE-01)

Quick Facts

Study Start:2022-05-04

Study Completion:2027-03-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05347771

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Daniel J. Jackson, M.D.

STUDY_CHAIR

University of Wisconsin School of Medicine and Public Health; Division of Allergy & Immunology

Study Locations (Sites)

Children's Hospital Colorado: Allergy Program

Aurora, Colorado, 80045

United States

Children's National Medical Center: Children's Research Institute

Washington D.C., District of Columbia, 20010

United States

Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology

Chicago, Illinois, 60611

United States

Boston Children's Hospital: Department of Immunology

Boston, Massachusetts, 02215

United States

Washington University at St. Louis

St Louis, Missouri, 63110

United States

Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute

New York, New York, 10029

United States

Columbia University Medical Center: Division of Pediatric Pulmonology

New York, New York, 10032

United States

Cincinnati Children's Hospital Medical Center: Asthma Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Daniel J. Jackson, M.D., STUDY_CHAIR, University of Wisconsin School of Medicine and Public Health; Division of Allergy & Immunology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-04

Study Completion Date2027-03-15

Study Record Updates

Study Start Date2022-05-04

Study Completion Date2027-03-15

Terms related to this study

Keywords Provided by Researchers

asthma
CAUSE
PANDA
T2
dupilumab

Additional Relevant MeSH Terms

Asthma