XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States

Part of paid clinical trials in East Hanover, New Jersey.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05157087
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab prescription. "Responders" were defined as individuals with at least 4 administrations of omalizumab.

Study Details

A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11, with omalizumab use over 24 months

Key Dates

First listed
Dec 14, 2021
Start date
Mar 1, 2020
Status verified
Dec 2021
Primary completion
Dec 1, 2020
Completion
Dec 1, 2020

Study Design

Enrollment
16,246 participants (actual)

Arms

  • Arm: Commercial Population
    Individuals with at least one omalizumab prescription in the Marketscan commercial claims during the identification period (07/07/2016 - 12/31/2018)
  • Arm: Medicaid Population
    Individuals with at least one omalizumab prescription in the Truven Medicaid claims during the identification period (07/07/2016 - 12/31/2018)

Primary Outcome Measure

Proportion of patients with uncontrolled asthma (impairment + risk criteria) post omalizumab treatment initiation [ Time Frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Novartis Investigational SiteEast HanoverNew Jersey07936-1080-

Find similar trials in East Hanover, NJ

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By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Novartis Investigational Site· East Hanover, NJ

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