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

Asthma Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

This was a retrospective database pre-post cohort study, identifying asthmatic patients with omalizumab use over 24 months. Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab claims. "Responders" were defined as individuals with at least 4 omalizumab claims. Descriptive statistics are provided for both groups, but outcomes are reported only for responders.

For this study, any persons from the Marketscan database with an asthma diagnosis and >= 1 omalizumab prescription/administration during the index period were identified. From this patient population the inclusion and exclusion criteria were applied, resulting in the final study cohort. Each person was assigned an index date based on their initial use of omalizumab.

Study Period: 07/07/2015 - 12/31/2019 Index Period: 07/07/2016 - 12/31/2018 Index Date: The date of the first medical or pharmacy claim of omalizumab Baseline Period (pre-index): 12 months before index date Follow up Period (post-index): 12 months after index date

The MarketScan® Claims Database (including commercial and Medicaid claims) was used. The claims database included data from 07/08/2015 - 12/31/2019. The MarketScan® Databases capture personspecific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The current study used the Commercial, Medicare Supplemental and Multi-State Medicaid Databases. ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT05157087
• Study type: Observational
• Source: Novartis
• Status: Completed
• Start date: March 1, 2020
• Completion date: December 1, 2020