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

Phase 3

Withdrawn

• Conditions: Allergic Rhinitis
• Interventions: Drug: EMS Mometasone gel; Drug: Mometasone spray nasal

• Registration Number: NCT02953379
• Lead Sponsor: EMS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-02
• Study Start: 2019-05
• Primary Completion: 2019-12
• Study Completion: 2020-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMS Mometasone gel	EMS Mometasone gel	The patient should administer 2 spray in each nostril, once daily.
Mometasone spray nasal	Mometasone spray nasal	The patient should administer 2 spray in each nostril, once daily.

Primary Outcome Measures

Name	Time	Method
Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief	14 days

Secondary Outcome Measures

Name	Time	Method
Safety will be evaluated by the adverse events occurrences	14 days