Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Keywords: Xolair
seasonal allergic rhinitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was patients with seasonal allergic rhinitis.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Overall improvement rate of disease by physicians
timeFrame: week 24
measure: Disease severity of seasonal allergic rhinitis
timeFrame: Up to 24 weeks
measure: Individual symptom severity of seasonal allergic rhinitis
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Inazawa
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Ichikawa-city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Inzai
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Chikusei City
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Sagamihara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Neyagawa
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Chiyoda
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Nagasaki
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: