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

National, Multicenter, Randomized, Simple-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis in Participants With Age Greater Than or Equal to 12 Years.

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.

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.