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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-03-01

Brief Summary

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

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Detailed Description

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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

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Omalizumab

Intervention Type 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.

(Desloratadine group).

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

Group Type ACTIVE_COMPARATOR

Omalizumab

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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desloratadin + montelukast

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No