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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648930
• Other study ID #: CIGE025F1401
• Status: Completed
• Start date: January 27, 2021
• Est. completion date: November 3, 2022

Study information

• Verified date: August 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 3, 2022
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

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

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Chikusei City	Ibaraki
Japan	Novartis Investigative Site	Chiyoda	Tokyo
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Ichikawa-city	Chiba
Japan	Novartis Investigative Site	Inazawa	Aichi
Japan	Novartis Investigative Site	Inzai	Chiba
Japan	Novartis Investigative Site	Kumamoto
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Nagasaki
Japan	Novartis Investigative Site	Neyagawa	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Sagamihara	Kanagawa
Japan	Novartis Investigative Site	Sagamihara-city	Kanagawa
Japan	Novartis Investigative Site	Saitama

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall improvement rate of disease by physicians	The investigator comprehensively assessed the therapeutic effect of Xolair on seasonal allergic rhinitis at the last visit on the basis of the patient's condition before the start of Xolair and during the clinical course thereafter, as "markedly improved", "moderately improved", "slightly improved", "no change" or "worsened"	week 24
Secondary	Disease severity of seasonal allergic rhinitis	The investigator comprehensively assessed the severity of seasonal allergic rhinitis on the basis of each seasonal allergic rhinitis symptom, test results, and the degree of visually examined local changes at each visit, as "very severe", "severe", "moderate", "mild" or "no symptom"	Up to 24 weeks
Secondary	Individual symptom severity of seasonal allergic rhinitis	The investigator assessed the severity of each seasonal allergic rhinitis symptom(sneezing, nasal discharge, nasal obstruction, difficulty in daily activity) at each visit in accordance with the criteria in the Practical Guideline for the Management of Allergic Rhinitis in Japan (2016)	Up to 24 weeks

External Links

•   Results for CIGE025F1401 that is getting linked from the Novartis Clinical Trials Website