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

EMS

Status and phase

Withdrawn

Phase 3

Conditions

Allergic Rhinitis

Treatments

Drug: MOMETASONE FUROATE

Drug: MAGNÓLIA NASAL GEL

Study type

Interventional

Funder types

Industry

Identifiers

NCT04670653

EMS0619 - MAGNÓLIA

Details and patient eligibility

About

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.

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.