NCT04648930

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The observation period lasted for up to 24 weeks, with Day 1 defined as the start date of Xolair treatment. It should be noted that, because the duration of Xolair treatment depends on the pollen dispersal situation and other factors, patients who completed or discontinued Xolair treatment before the visit at 24 weeks after the start of treatment were followed up until the date of last dose of Xolair + 30 days, and the results were recorded in the CRF.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Xolair	There was no treatment allocation. Patients administered Xolair by prescription that started before inclusion of the patient into the study were enrolled.

Timeline

• Start date: 2021-01-27
• Primary completion: 2022-11-03
• Completion: 2022-11-03
• First posted: 2020-12-02
• Last updated: 2026-03-16