Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.

Official Title
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Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Adults

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: EMS Mometasone gel
* Drug: Mometasone spray nasal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Consent of the patient; Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma); Exclusion Criteria: Patients with any clinically significant disease that in the investigator is opinion can ´t participate in the study; Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial; Patients with history of hypersensitivity to any of the formula compounds; Participation in clinical trial in the year prior to this study; Pregnancy or risk of pregnancy and lactating patients; Patients who were in use of drugs that can interfere with evaluation; Decongestants dependent patients or patients receiving allergen specific immunotherapy; Patients on treatment with monoamine oxidase inhibitors (MAOIs); History of hypertension, coronary artery disease, cardiac arrhythmias, glaucoma, hyperthyroidism and / or prostatic hypertrophy.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMS Mometasone gel<br>The patient should administer 2 spray in each nostril, once daily. | Drug: EMS Mometasone gel<br>* The patient should administer 2 spray in each nostril, once daily.<br>|
| Active Comparator: Mometasone spray nasal<br>The patient should administer 2 spray in each nostril, once daily. | Drug: Mometasone spray nasal<br>* The patient should administer 2 spray in each nostril, once daily.<br>* Other names: Nasonex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by the adverse events occurrences |  | 14 days |