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

Phase 3

Withdrawn

• Conditions: Allergic Rhinitis
• Interventions: Drug: MAGNÓLIA NASAL GEL; Drug: MOMETASONE FUROATE

• Registration Number: NCT04670653
• Lead Sponsor: EMS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-17
• Status Verified: 2022-08
• Study Start: 2022-08-01
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-05
• Primary Completion: 2023-07
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAGNÓLIA	MAGNÓLIA NASAL GEL	Two applications in each nostril, once a day.
MOMETASONE FUROATE	MOMETASONE FUROATE	Two applications in each nostril, once a day.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the reflective total nasal symptom score (rESN) averaged over the entire treatment period.	4 weeks	The participant will answer the nasal symptom score (together with their parents or guardians, for participants with less than 18 years old) every 12 hours, in the participant's diary. The rESN will be the average of the two measurements of the day.

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events recorded during the study.	6 to 10 weeks