Protocol CAUSE-03 / CHEETAH

Part of paid clinical trials in Aurora, Colorado.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06136091
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Accepted

Study Details

This is a one-year longitudinal, observational study of 250 urban children and adolescents with asthma and 60 without asthma, ages 6-17 years old. Participants with asthma will require daily controller therapy with inhaled corticosteroids ICS (at least Step 2 therapy). Those without asthma cannot have used asthma medications in the year prior to enrollment and cannot demonstrate bronchodilator reversibility at baseline. Phenotypic characteristics will be established at baseline, and the participants will be seen at scheduled visits over 12 months. Each participant will be asked to monitor and self-report cold symptoms and will be asked to complete up to three cold visits

Key Dates

First listed
Nov 18, 2023
Start date
May 8, 2024
Status verified
Jun 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
310 participants (estimated)

Arms

  • Arm: Asthma group
    Participants ages 6 to 17 year old in the asthma group will be seen in clinic quarterly for one year, during periods of disease control when they are not on systemic corticosteroids (SCS)
  • Arm: Non-asthma group
    Participants in the non-asthma group will be seen at two scheduled visits in clinic at 3 and 12 months and will have telephone visits at 6 and 9 months

Primary Outcome Measure

Asthma disease activity measured by the number of exacerbations during the 12-month observation period [ Time Frame: Month 0 to Month 12 ]

Locations (8)

FacilityCityStateZIPSite coordinators
Children's Hospital Colorado: Allergy ProgramAuroraColorado80045
Juana Cerna-Sanchez
[email protected]
720-777-8384
Children's National Medical Center: Children's Research InstituteWashington D.C.District of Columbia20010
Cassandra Pelkey
[email protected]
202-476-2606
Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and ImmunologyChicagoIllinois60611
Sarah Godley
[email protected]
312-227-6454
Boston Children's Hospital: Department of ImmunologyBostonMassachusetts02215
Crystal Miranda
[email protected]
857-218-5245
Boston University School of Medicine: Pulmonary CenterBostonMassachusetts02118
Daniel Mompoint
[email protected]
617-358-7583
Columbia University Medical Center: Division of Pediatric PulmonologyNew YorkNew York10032
Marcela Pierce
[email protected]
347-344-3000
Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology InstituteNew YorkNew York10029
Joseph Martinez
[email protected]
914-920-8163
Cincinnati Children's Hospital Medical Center: Asthma CenterCincinnatiOhio45229
Molly Brausch-Bradner
[email protected]
513-803-0028

Find similar trials in Aurora, CO

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Children's Hospital Colorado: Allergy Program· Aurora, COChildren's National Medical Center: Children's Research Institute· Washington D.C., DCAnn & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology· Chicago, ILBoston Children's Hospital: Department of Immunology· Boston, MABoston University School of Medicine: Pulmonary Center· Boston, MAColumbia University Medical Center: Division of Pediatric Pulmonology· New York, NY

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