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 | Completed

• 1 other identifier: CIGE025F1401
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Allergic Rhinitis

Keywords

Xolair; seasonal allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• 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

  The number of patients with each events and incidences (%) will be calculated by System Organ Class (SOC) and Preferred Term (PT). SAEs are defined as AEs meeting the criteria of seriousness and adverse events with a fatal outcome. ADRs are defined as AEs for which a causal relationship with Xolair is not ruled out by the investigator.

  up to 24 weeks

Secondary Outcomes (3)

• Overall improvement rate of disease by physicians

  week 24

• Disease severity of seasonal allergic rhinitis

  Up to 24 weeks

• Individual symptom severity of seasonal allergic rhinitis

  Up to 24 weeks

Study Arms (1)

Xolair

S.C. Injection

Drug: Xolair

Interventions

Xolair DRUG

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

Also known as: Omalizumab

Xolair

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population was patients with seasonal allergic rhinitis.

You may qualify if:

• 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:
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: January 27, 2021
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (16)