Overview

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

Status:
Withdrawn
Trial end date:
2020-05-01
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).