Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Magnólia nasal gel in the treatment of moderate-severe persistent or moderate-severe intermittent allergic rhinitis.

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

Details

• Lead Sponsor: EMS
• Treatments: Mometasone Furoate

Criteria

Inclusion Criteria:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;

• Participants of both sexes, with age greater than or equal to 12 years;

• Clinical diagnosis of moderate-severe persistent or moderate-severe intermittent allergic rhinitis, according to the ARIA classification;

• Present the general status of rhinitis as moderate or severe;

• Total nasal symptom score greater than or equal to 6 points, with congestion and one or more of the other symptoms present (itching, runny nose, and sneezing) with a score greater than or equal to 2 at the screening visit;

• Present skin sensitization test to at least one aeroallergen;

Exclusion Criteria:

• Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;

• History of alcohol abuse or illicit drug use;

• Participation in a clinical trial in the year before this study;

• Pregnancy or risk of pregnancy and lactating patients;

• Known hypersensitivity to the formula components used during the clinical trial;

• Participants who present other clinical forms of rhinitis, such as, but not restricted to medicated rhinitis, vasomotor and atrophic;

• Participants dependent on decongestants (nasal or oral) or receiving allergen-specific immunotherapy;

• Participants with suggestive signs of upper airways bacterial infection;

• Participants with grade II or III septum deviation and/or presence of nasal polyps or other conditions that lead to nasal obstruction;

• Concomitant chronic or intermittent use of decongestants, antihistamines, or corticosteroids by inhalation, oral, intramuscular, or intravenous;

• Concomitant use of potent topical corticosteroids.