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

NCT06806826 | Completed Phase 4

• 1 other identifier: 19.12.2018/09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

We aimed to evaluate the usability and efficacy of omalizumab in allergic rhinitis and its potential as an alternative treatment option.

Conditions

Allergic Rhinitis

Keywords

allergic rhinitis; omalizumab

Outcome Measures

Primary Outcomes (1)

• 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.

  Patients were followed up for 3 months after starting treatment.

Study Arms (2)

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).

Drug: Omalizumab

(Desloratadine group).

ACTIVE COMPARATOR

patients with allergic rhinitis received Montelukast 10 mg plus Desloratadine 5 mg daily (Desloratadine group).

Drug: Omalizumab

Interventions

Omalizumab DRUG

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.

Also known as: desloratadin + montelukast

(Desloratadine group).; Omalizumab group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Yuzuncu Yıl üniversity dursun odabaş medical center

Van, tuşba, 65090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Omalizumab; montelukast

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asst.prof.dr

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 4, 2025
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: March 1, 2020
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)