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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: 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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 813 0043
    • Novartis Investigative Site
  • Kumamoto, Japan, 860-0814
    • Novartis Investigative Site
  • Kyoto, Japan, 604-0837
    • Novartis Investigative Site
  • Kyoto, Japan, 604-8152
    • Novartis Investigative Site
  • Nagasaki, Japan, 850-0057
    • Novartis Investigative Site
  • Osaka, Japan, 545-8586
    • Novartis Investigative Site
  • Osaka, Japan, 544-0033
    • Novartis Investigative Site
  • Saitama, Japan, 331-0802
    • Novartis Investigative Site
  • Aichi
    • Inazawa, Aichi, Japan, 495-0002
      • Novartis Investigative Site
  • Chiba
    • Ichikawa-city, Chiba, Japan, 272-0143
      • Novartis Investigative Site
    • Inzai, Chiba, Japan, 270-1337
      • Novartis Investigative Site
  • Ibaraki
    • Chikusei City, Ibaraki, Japan, 308-0031
      • Novartis Investigative Site
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0231
      • Novartis Investigative Site
    • Sagamihara-city, Kanagawa, Japan, 252-0392
      • Novartis Investigative Site
  • Osaka
    • Neyagawa, Osaka, Japan, 572-0082
      • Novartis Investigative Site
  • Tokyo
    • Chiyoda, Tokyo, Japan, 102-0093
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population was patients with seasonal allergic rhinitis.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Xolair; S.C. Injection	Drug: Xolair; There was no treatment allocation. Patients administered Xolair by prescription that started before inclusion of the patient into the study were enrolled.; Other Names: Omalizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): November 3, 2022
• Study Completion (Actual): November 3, 2022

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Xolair; seasonal allergic rhinitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: CIGE025F1401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No