Preventing Asthma in High Risk Kids

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Boston Children's Hospital
Study ID
NCT02570984
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
24 Months - 47 Months
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    anti-ige injection
  • Placebo — DRUG
    placebo comparator arm, injection similar to active

Study Details

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.

Key Dates

Start date
Nov 27, 2018
Status verified
Dec 2025
Primary completion
Jan 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Active
    omalizumab 0.016 mg/kg/IU total IgE
  • Placebo Comparator: Placebo
    looks like active drug

Primary Outcome Measure

active asthma diagnosis [ Time Frame: Final 12 months during 2 year observation period off study drug ]

Locations (13)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016-
Rady Children's Hospital - San DiegoSan DiegoCalifornia92123-
Childrens Hospital ColoradoAuroraColorado80045-
Connecticut Children's HospitalHartfordConnecticut06106-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Emory UniversityAtlantaGeorgia30322-
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
Indiana University/Riley Children's HospitalIndianapolisIndiana46202-
Boston Children's HospitalBostonMassachusetts02115-
Washington UniversitySt LouisMissouri63110-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Texas Children's Hospital/Baylor College of MedicineHoustonTexas77030-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Phoenix, AZ

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Phoenix Children's Hospital· Phoenix, AZRady Children's Hospital - San Diego· San Diego, CAChildrens Hospital Colorado· Aurora, COConnecticut Children's Hospital· Hartford, CTChildren's National Medical Center· Washington D.C., DCEmory University· Atlanta, GA

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