CompletedNot Applicable

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

50 participantsStarted 2021-01-27

Plain-language summary

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.

Who can participate

Age range12 Years – 17 Years

SexALL

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Inclusion criteria

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

What they're measuring

Proportions of patients with Adverse events (AEs), Serious AEs, AEs leading to discontinuation of Xolair treatment, Adverse drug reactions (ADRs), Serious ADRs, ADRs leading to discontinuation of Xolair treatment

Timeframe: up to 24 weeks

Trial details

NCT IDNCT04648930

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-11-03

View on ClinicalTrials.gov More Allergic Rhinitis trials