The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study (rhinitis)

January 28, 2025 updated by: Semra Ağırbaş, Yuzuncu Yıl University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Tuşba
      • VAN, Tuşba, Turkey, 65090
        • Yuzuncu Yıl üniversity dursun odabaş medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Those who gave informed consent and wanted to participate in the study and did not have any additional systemic or nasal diseases were included.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omalizumab group
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).
Drug: Omalizumab
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.
Other Names:
  • desloratadin + montelukast
Active Comparator: (Desloratadine group).
patients with allergic rhinitis received Montelukast 10 mg plus Desloratadine 5 mg daily (Desloratadine group).
Drug: Omalizumab
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.
Other Names:
  • desloratadin + montelukast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Patients were followed up for 3 months after starting treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19.12.2018/09

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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