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

• Status: Withdrawn
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Mometasone Furoate

Criteria

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.