Seasonal Allergic RhinitisNCT04489121
The Efficacy of Preseasonal Omalizumab Treatment
A study testing Omalizumab in people with Seasonal Allergic Rhinitis, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Allergic rhinitis (AR) is induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR). In recent years, biologics have become promising drugs for allergic diseases. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2020to 1 Oct 2020
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female outpatients aged 18 to 60 years (inclusive).
- With history of SAR for at least two years, with/without conjunctivitis and without asthma
- Two or more nasal symptoms scores were ≥ 2 points during July - October in the last year.
- Sensitised to common autumn pollens including sagewort and ragweed (a specific IgE level ≥ 3.5 kU/L).
- Patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol.
- Patients who are able to understand the information given and the consent and complete the daily record card.
Who cannot join
- Patients with oral diseases/ allergies within the run-in period.
- Patients accepted any kind of operations within 4 weeks of the run-in period.
- Patients applied for systemic glucocorticoids within 4 weeks in the run-in period.
- Patients with PAR.
- Patients with any nasal condition that could confound the results of the study (chronic rhinitis, chronic rhinosinusitis with/without polyps).
- Whatever the co-sensitization leading to clinically relevant AR, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study.
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- patients with comorbidity of severe asthma.
- Patients applying beta-antagonist (local or systemic appliance).
- Pregnant, breast-feeding / sexually active women of childbearing potential.
- Patients treated with AIT for pollens within 3 years.
- Participation in any clinical study within the 3 months of the run-in period.
- Patients at risk of non-compliance..
- Patients with immunologic suppression, diabetes mellitus, autonomic neuropathy, coronary heart disease or hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Preseasonal Omalizumab Treatment in Seasonal Allergic Rhinitis Patients
Allergic rhinitis (AR) is induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR).
In recent years, biologics have become promising drugs for allergic diseases. The efficacy and safety of Omalizumab in treating SAR have been well proven by previous studies. However, the efficacy in preseasonal treatment for SAR has not yet been studied before.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Omalizumab
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season.
| Study group | Role | What they receive |
|---|---|---|
| omalizumab preseasonal treatment | Experimental | For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season. Rescue medication could be used during pollen seasons. Receives: Drug: Omalizumab |
| control | No intervention | No preseasonal treatment was performed. Rescue medication could be used during pollen seasons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of total nasal symptoms scores
Measured: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
Rescue medication score
when the symptoms were very severe and could not tolerated, the patients could use loratadine as rescue medication.
The need for rescue medication was assessed as rescue medication score (RMS), analyzed as the weekly sum of daily use of Loratadine (10mg/d, equivalent to 1 point) or nasal corticosteroid spray (2 points)
Measured: at week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
Secondary outcomes (3)
the change of quality of life
mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ)
Measured: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
adverse events
Any adverse event following injection was assessed by physicians and patients. Patients in the Omalizumab group are instructed to record any unexpected signs, symptoms, and feelings during the subcutaneous injection of Omalizumab.
Measured: one hour after injection in the Omalizumab group
eosinophilic indicators in nasal secretions
The level of eosinophilic indicators; Charcot-Leyden crystal (CLC) , Cystatin SN
Measured: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start28 Jul 2020
- Primary completion26 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luo Zhang, Beijing Tongren Hospital
- Investigators
- Luo Zhang, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489121
- Sponsor's protocol ID
- Preseasonal-OMA-AR
- Status last verified
- Jan 2021
- First submitted
- 22 Jul 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Preseasonal Omalizumab Treatment in Seasonal Allergic Rhinitis Patients
- ClinicalTrials.gov ID
- NCT04489121
- Acronym / sponsor ID
- Preseasonal-OMA-AR
- Conditions
- Seasonal Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 26 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 28 Jul 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.
Allergic rhinitis (AR) is induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR).
In recent years, biologics have become promising drugs for allergic diseases. The efficacy and safety of Omalizumab in treating SAR have been well proven by previous studies. However, the efficacy in preseasonal treatment for SAR has not yet been studied before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omalizumab preseasonal treatment | Experimental | Drug: OmalizumabFor patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season. Rescue medication could be used during pollen seasons. |
| control | No intervention | –No preseasonal treatment was performed. Rescue medication could be used during pollen seasons. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female outpatients aged 18 to 60 years (inclusive).
- With history of SAR for at least two years, with/without conjunctivitis and without asthma
- Two or more nasal symptoms scores were ≥ 2 points during July - October in the last year.
- Sensitised to common autumn pollens including sagewort and ragweed (a specific IgE level ≥ 3.5 kU/L).
- Patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol.
Key exclusion criteria (13 listed)
- Patients with oral diseases/ allergies within the run-in period.
- Patients accepted any kind of operations within 4 weeks of the run-in period.
- Patients applied for systemic glucocorticoids within 4 weeks in the run-in period.
- Patients with PAR.
- Patients with any nasal condition that could confound the results of the study (chronic rhinitis, chronic rhinosinusitis with/without polyps).
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 |
|---|---|---|
| OmalizumabFor patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season. | Drug | omalizumab preseasonal treatment |
Primary outcome
the change of total nasal symptoms scores
Time frame: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
Rescue medication score
Time frame: at week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
when the symptoms were very severe and could not tolerated, the patients could use loratadine as rescue medication. The need for rescue medication was assessed as rescue medication score (RMS), analyzed as the weekly sum of daily use of Loratadine (10mg/d, equivalent to 1 point) or nasal corticosteroid spray (2 points)
3 secondary outcomes
the change of quality of life
Time frame: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
adverse events
Time frame: one hour after injection in the Omalizumab group
eosinophilic indicators in nasal secretions
Time frame: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
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 28 Jan 2021.
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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.
Luo Zhang principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omalizumab in people with Seasonal Allergic Rhinitis, run by Beijing Tongren Hospital at 1 site in China.
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 6 inclusion and 13 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
the change of total nasal symptoms scores (time frame: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).). The study lists 2 primary outcomes in all. 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 28 Jan 2021.