Status:
WITHDRAWN
Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis
Lead Sponsor:
EMS
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04670653
Start Date
August 1 2022
End Date
October 1 2023
Last Update
August 5 2022
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