XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States
Completed
Conditions studied: Asthma
In brief
A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11, with omalizumab use over 24 months
Key facts
- Study ID
- NCT05157087
- Run by
- Novartis Pharmaceuticals
- People needed
- 16246
- Starts
- 2020-03-01
- Expected to finish
- 2020-12-01
- Last updated by the study team
- 2021-12-16
Who can join
Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- We used all eligible Marketscan beneficiaries with an asthma diagnosis and omalizumab use between 07/07/2016 - 12/31/2018 (index period). Continuous enrollment in the Marketscan database was required to ensure the availability of claims data to capture study outcomes and covariates.
- Omalizumab cohort was defined as ≥1 prescription claims within the index period, with the date of first dispensing deemed the index date.
- Asthma was defined by ≥1 diagnosis code in any available diagnosis field on or prior to index date.
- ICD-9-CM: 493.xx OR ICD-10-CM: J45.x
- 6-11 years of age at the time of index
- ≥12-months pre-index and ≥12-months post-index continuous eligibility in medical and pharmacy benefits
- Enrollment gap of ≤30 days will be considered continuous enrollment
You may not qualify if…
- Patients were excluded from the study if they had one or more of the following:
- Bronchial Thermoplasty at any time during data capture. Current Procedural Terminology (CPT): 31660, 31661
- Prior asthma-indicated biologic use during the 12 months pre or post-index
- Omalizumab:
- NDC: 50242004062; 50242004201 or HCPCS: J2357; S0107; C9217
- Mepolizumab:
- NDC: 00173088101, 00173088185 or HCPCS: J2182
- Reslizumab:
- NDC: 5931061031 or HCPCS: J2786
- Benralizumab:
- NDC: 0310173030 or HCPCS: C9466
- Dupilumab:
- NDC: 0024591400 or 0024591800
Where it is running
- Novartis Investigational Site — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
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