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

EMS

Status and phase

Withdrawn

Phase 3

Conditions

Allergic Rhinitis

Treatments

Drug: EMS Mometasone gel

Drug: Mometasone spray nasal

Study type

Interventional

Funder types

Industry

Identifiers

NCT02953379

EMS1315

Details and patient eligibility

About

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.

Sex

All

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

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.