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

NCT04670653 | Withdrawn Phase 3 DMC

• 1 other identifier: EMS0619 - MAGNÓLIA
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the reflective total nasal symptom score (rESN) averaged over the entire treatment period.

  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.

  4 weeks

Secondary Outcomes (1)

• Incidence and severity of adverse events recorded during the study.

  6 to 10 weeks

Study Arms (2)

MAGNÓLIA

EXPERIMENTAL

Two applications in each nostril, once a day.

Drug: MAGNÓLIA NASAL GEL

MOMETASONE FUROATE

ACTIVE COMPARATOR

Two applications in each nostril, once a day.

Drug: MOMETASONE FUROATE

Interventions

MAGNÓLIA NASAL GEL DRUG

Magnólia nasal gel spray

MAGNÓLIA

MOMETASONE FUROATE DRUG

Mometasone furoate nasal spray

MOMETASONE FUROATE

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: August 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08