Allergic RhinitisPhase 4rhinitisNCT06806826
The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study
A Phase 4 study testing Omalizumab in people with Allergic Rhinitis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to evaluate the usability and efficacy of omalizumab in allergic rhinitis and its potential as an alternative treatment option. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Omalizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Mar 2020
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who gave informed consent and wanted to participate in the study and did not have any additional systemic or nasal diseases were included.
Who cannot join
- under 18 years old,
- over 65 years old,
- with systemic comorbidities (diabetes mellitus, hypertension, chronic renal failure, hypothyroidism, etc.)
- patients with rhinosinusitis, nasal polyps, nasal septal deviation, tumors, smoking and nasal surgery, and non-compliant patients were excluded from this study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuzuncu Yıl üniversity dursun odabaş medical center
Van, tuşba, 65090
About this study
Official title: Evaluatıon of the Effectıveness of Omalızumab Treatment In Patıents Wıth Allergıc Rhınıtıs
We aimed to evaluate the usability and efficacy of omalizumab in allergic rhinitis and its potential as an alternative treatment option.
Read the detailed description
The study was conducted to determine the effectiveness of omalizumab on symptoms in patients diagnosed with allergic rhinitis and to compare it with current medical treatment options.
- Conditions
- Allergic Rhinitis
- Being tested
- Omalizumab
- Keywords
- allergic rhinitis, omalizumab
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called desloratadin + montelukast
The patients in the study group were started on omalizumab and intranasal fluticasone propionate. Omalizumab was administered subcutaneously to these patients at a dose of 300 mg once a month. . Twenty-five patients in the control group were started on intranasal fluticasone propionate spray and a tablet containing 5 mg desloratadine+10 mg montelukast sodium at the same dose and in the same manner as the patients in the study group. The patients were asked to use 100 mg of suspension equivalent to 50 micrograms of fluticasone propionate as two sprays into each nostril once daily and to use the tablet once daily. Patients in both groups were asked to fill out the visual analog scale and their total Ig E levels were checked. Patients who were called for a check-up after eight to ten weeks were evaluated again with the visual analog scale.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab group | Active comparator | Between December 2018 and November 2019, 25 patients with allergic rhinitis and chronic urticaria and 25 patients with allergic rhinitis only were included in the study. Patients with allergic rhinitis and chronic urticaria received Omalizumab (300 mg/month) (Omalizumab group). Receives: Drug: Omalizumab |
| (Desloratadine group). | Active comparator | patients with allergic rhinitis received Montelukast 10 mg plus Desloratadine 5 mg daily (Desloratadine group). Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
omalizumab treatment process
Vas scores including runny nose, nasal congestion, sneezing, tearing and itching in the eyes were compared before and 3 months after omalizumab treatment.
Measured: Patients were followed up for 3 months after starting treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Mar 2020
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between December 2018 and November 2019, 25 patients with both allergic rhinitis and chronic urticaria and 25 patients with allergic rhinitis only were included in the study. Patients with both allergic rhinitis and chronic urticaria received Omalizumab (300 mg/month) (Omalizumab group), while patients with allergic rhinitis received Montelukast 10 mg plus Desloratadine 5 mg daily (Desloratadine group). In addition, both groups received fluticasone propionate nasal spray (100 mcg/day in each nostril). At baseline and 8-10 weeks after the start of treatments (follow-up), allergic rhinitis symptoms such as nasal congestion, rhinorrhea, sneezing, and itchy eyes and quality of life were assessed. A self-report measure, a 10-cm linear visual analog scale (VAS), was used for the assessments.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semra Ağırbaş, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806826
- Sponsor's protocol ID
- 19.12.2018/09
- Acronym
- rhinitis
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 4 Feb 2025
- 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluatıon of the Effectıveness of Omalızumab Treatment In Patıents Wıth Allergıc Rhınıtıs
- ClinicalTrials.gov ID
- NCT06806826
- Acronym / sponsor ID
- rhinitis / 19.12.2018/09
- Conditions
- Allergic Rhinitis
- Keywords
- allergic rhinitis, omalizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 4 Feb 2025 (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.
We aimed to evaluate the usability and efficacy of omalizumab in allergic rhinitis and its potential as an alternative treatment option.
Detailed description
The study was conducted to determine the effectiveness of omalizumab on symptoms in patients diagnosed with allergic rhinitis and to compare it with current medical treatment options.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Between December 2018 and November 2019, 25 patients with both allergic rhinitis and chronic urticaria and 25 patients with allergic rhinitis only were included in the study. Patients with both allergic rhinitis and chronic urticaria received Omalizumab (300 mg/month) (Omalizumab group), while patients with allergic rhinitis received Montelukast 10 mg plus Desloratadine 5 mg daily (Desloratadine group). In addition, both groups received fluticasone propionate nasal spray (100 mcg/day in each nostril). At baseline and 8-10 weeks after the start of treatments (follow-up), allergic rhinitis symptoms such as nasal congestion, rhinorrhea, sneezing, and itchy eyes and quality of life were assessed. A self-report measure, a 10-cm linear visual analog scale (VAS), was used for the assessments.
| Arm | Type | Receives |
|---|---|---|
| Omalizumab group | Active comparator | Drug: OmalizumabBetween December 2018 and November 2019, 25 patients with allergic rhinitis and chronic urticaria and 25 patients with allergic rhinitis only were included in the study. Patients with allergic rhinitis and chronic urticaria received Omalizumab (300 mg/month) (Omalizumab group). |
| (Desloratadine group). | Active comparator | Drug: Omalizumabpatients with allergic rhinitis received Montelukast 10 mg plus Desloratadine 5 mg daily (Desloratadine group). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those who gave informed consent and wanted to participate in the study and did not have any additional systemic or nasal diseases were included.
Key exclusion criteria (4 listed)
- under 18 years old,
- over 65 years old,
- with systemic comorbidities (diabetes mellitus, hypertension, chronic renal failure, hypothyroidism, etc.)
- patients with rhinosinusitis, nasal polyps, nasal septal deviation, tumors, smoking and nasal surgery, and non-compliant patients were excluded from this study.
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 |
|---|---|---|
| OmalizumabAlso: desloratadin + montelukastThe patients in the study group were started on omalizumab and intranasal fluticasone propionate. Omalizumab was administered subcutaneously to these patients at a dose of 300 mg once a month. . Twenty-five patients in the control group were started on intranasal fluticasone propionate spray and a tablet containing 5 mg desloratadine+10 mg montelukast sodium at the same dose and in the same manner as the patients in the study group. The patients were asked to use 100 mg of suspension equivalent to 50 micrograms of fluticasone propionate as two sprays into each nostril once daily and to use the tablet once daily. Patients in both groups were asked to fill out the visual analog scale and their total Ig E levels were checked. Patients who were called for a check-up after eight to ten weeks were evaluated again with the visual analog scale. | Drug | (Desloratadine group)., Omalizumab group |
Primary outcome
omalizumab treatment process
Time frame: Patients were followed up for 3 months after starting treatment.
Vas scores including runny nose, nasal congestion, sneezing, tearing and itching in the eyes were compared before and 3 months after omalizumab treatment.
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 4 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omalizumab in people with Allergic Rhinitis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 4 Feb 2025. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
omalizumab treatment process (time frame: Patients were followed up for 3 months after starting treatment.). 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 4 Feb 2025.