Allergic RhinitisNCT04648930
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
An observational study of Allergic Rhinitis, run by Novartis Pharmaceuticals.
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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Xolair
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2021to 3 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population was patients with seasonal allergic rhinitis.
Who may be able to join
- 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)
Who cannot join
- 1. Patients with a history of hypersensitivity to any of the Xolair ingredients
About this study
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.
Read the 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
- Being tested
- Xolair
- Keywords
- Xolair, seasonal allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XolairDrug
Also called Omalizumab
There was no treatment allocation. Patients administered Xolair by prescription that started before inclusion of the patient into the study were enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Xolair | S.C. Injection Receives: Drug: Xolair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 weeks
Secondary outcomes (3)
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"
Measured: 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"
Measured: 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)
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start27 Jan 2021
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648930
- Sponsor's protocol ID
- CIGE025F1401
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2020
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04648930
- Acronym / sponsor ID
- CIGE025F1401
- Conditions
- Allergic Rhinitis
- Keywords
- Xolair, seasonal allergic rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xolair | – | Drug: XolairS.C. Injection |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population was patients with seasonal allergic rhinitis.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- 1. Patients with a history of hypersensitivity to any of the Xolair ingredients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XolairAlso: OmalizumabThere was no treatment allocation. Patients administered Xolair by prescription that started before inclusion of the patient into the study were enrolled. | Drug | Xolair |
Primary outcome
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
Time frame: up to 24 weeks
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.
3 secondary outcomes
Overall improvement rate of disease by physicians
Time frame: week 24
Disease severity of seasonal allergic rhinitis
Time frame: Up to 24 weeks
Individual symptom severity of seasonal allergic rhinitis
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.