Back to resultsEfficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis
Primary Purpose
Allergic Rhinitis
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MAGNÓLIA NASAL GEL
MOMETASONE FUROATE
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic Rhinitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MAGNÓLIA
MOMETASONE FUROATE
Arm Description
Two applications in each nostril, once a day.
Two applications in each nostril, once a day.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence and severity of adverse events recorded during the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04670653
Brief Title
Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis
Official Title
National, Multicenter, Randomized, Simple-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis in Participants With Age Greater Than or Equal to 12 Years.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MAGNÓLIA
Arm Type
Experimental
Arm Description
Two applications in each nostril, once a day.
Arm Title
MOMETASONE FUROATE
Arm Type
Active Comparator
Arm Description
Two applications in each nostril, once a day.
Intervention Type
Drug
Intervention Name(s)
MAGNÓLIA NASAL GEL
Intervention Description
Magnólia nasal gel spray
Intervention Type
Drug
Intervention Name(s)
MOMETASONE FUROATE
Intervention Description
Mometasone furoate nasal spray
Primary Outcome Measure Information:
Title
Change from baseline in the reflective total nasal symptom score (rESN) averaged over the entire treatment period.
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events recorded during the study.
Time Frame
6 to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis
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