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Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged ≥ 12 Years and < 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies
Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged ≥ 12 Years and < 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies

NCT04648930

CompletedN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Allergic Rhinitis

Interventions: Xolair

This was a multicenter, uncontrolled, open-label, special drug use study to investigate the safety and efficacy of Xolair by collecting data in its clinical setting in patients with severe to most severe seasonal allergic rhinitis aged ≥ 12 years and \< 18 years whose symptoms were inadequately controlled despite to conventional therapies and used Xolair.

Eligibility overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

1. Patients who used Xolair in accordance with the instructions of package insert
2. Patients aged ≥ 12 years and \< 18 years at the start of Xolair
3. Patients who used Xolair for the following indication:

Indication: seasonal allergic rhinitis (only patients with severe to most severe symptoms whose symptoms were inadequately controlled despite to conventional therapies) 4. Patients having provided written consent to participate in this study before the start of Xolair in the relevant pollen season, in person and from their legally acceptable representative (legal representative)

Exclusion Criteria:

1\. Patients with a history of hypersensitivity to any of the Xolair ingredients