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

NCT ID: NCT04670653

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MAGNÓLIA

Two applications in each nostril, once a day.

Group Type: EXPERIMENTAL

MAGNÓLIA NASAL GEL

Intervention Type: DRUG

Magnólia nasal gel spray

MOMETASONE FUROATE

Two applications in each nostril, once a day.

Group Type: ACTIVE_COMPARATOR

MOMETASONE FUROATE

Intervention Type: DRUG

Mometasone furoate nasal spray

Interventions

MAGNÓLIA NASAL GEL

Magnólia nasal gel spray

Intervention Type: DRUG

MOMETASONE FUROATE

Mometasone furoate nasal spray

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EMS0619 - MAGNÓLIA

Identifier Type: -

Identifier Source: org_study_id