A Safety and Bioequivalence of a Mometasone Nasal Spray, 50 mcg/Actuation Compared With Nasonex® Nasal Spray 50 mcg/Actuation in the Relief of the Symptoms of Seasonal Allergic Rhinitis (SAR)

NCT01673659 | Completed Phase 3

• 1 other identifier: PRG-NY-12-008
• Study Type: interventional
• Target: 1,220
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study is to demonstrate bioequivalence (comparable safety and efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic rhinitis.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline for mean reflective Total Nasal Symptom Score (rTNSS)

  2 week treatment period

Secondary Outcomes (1)

• Mean Change from Baseline in the mean Instantaneous Total Nasal Symptom Score (iTNSS)

  2 weeks treatment period

Study Arms (3)

Test product

EXPERIMENTAL

Mometasone furoate 50 mcg/actuation Nasal Spray

Drug: Mometasone furoate

Reference product

ACTIVE COMPARATOR

Nasonex Nasal Spray

Drug: Nasonex Nasal Spray

Placebo Nasal Spray

PLACEBO COMPARATOR

vehicle of the test product

Drug: Placebo nasal spray

Interventions

Mometasone furoate DRUG

Test product

Nasonex Nasal Spray DRUG

Reference product

Placebo nasal spray DRUG

Placebo Nasal Spray

Eligibility Criteria

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

You may qualify if:

• Complete the informed consent/assent process.
• Male or female between 12-65 years of age.
• Female subjects of child-bearing potential must not be pregnant or nursing, must have a negative urine pregnancy test and abstain from sexual intercourse or use a reliable method of contraception during the study.
• Subjects will be eligible to participate if: a) Their total rTNSS is at least 6; b) Reflective rating for "nasal congestion/stuffy nose" is a score of \>2 at Visit 1; c) Reflective score of \>2 for at least one (1) of the remaining three (3) allergic rhinitis symptoms.
• A history (2 or more seasons) of seasonal allergy to at least one allergen known to be present during the study season, confirmed by a skin prick test. (A documented positive skin test within the previous 12 months is acceptable.)

You may not qualify if:

• Female who is pregnant or nursing, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.
• Subject has a history of hypersensitivity or allergy to Mometasone, any other corticosteroids or any of the other study medication ingredients.
• Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis (PAR) should be excluded from the study, unless the Investigator assesses that the patient's current signs and symptoms are a clear exacerbation of Seasonal Allergic Rhinitis (SAR), rather than chronic PAR.
• A total score of less than 6 on the rTNSS or a score less than 2 for "nasal congestion" or a score less than 2 for all of the remaining 3 symptoms.
• Subject has any condition or abnormality of the upper airway (ex: nasal polyps, obstruction, recent nasal surgery, structural abnormality, rhinitis medicamentosa, etc.) that, in the opinion of the Investigator, could interfere with administration of the product, evaluation of the subject's condition, or other aspect of the trial.
• Subject has experienced any upper respiratory tract infection or has experienced a sinus infection within the 30 days, or has a history of recurrent sinus infections i.e. acute or significant chronic sinusitis, preceding Visit 1.
• Subject has a history of asthma requiring chronic treatment within two years of study start.
• Subject lacks history of seasonal allergy to at least one allergen known to be present during the study season for at least the two preceding seasons.
• Subject has a negative skin test for all appropriate allergens known to be present during the study season.
• Treatment for oral Candidiasis within 30 days of starting the study, or a current oral Candidiasis infection.
• The subject has had recent exposure (30 days) or is at risk of being exposed to chicken pox or measles.
• Patients with any untreated fungal, bacterial, systemic viral infections within the previous 30 days.
• Subject requires treatment with systemic corticosteroids for any condition, or has received systemic or nasal steroids within the 30 days preceding Visit 1. Hormone replacement therapy is allowed, on condition that the subject has been on a stable dosing regimen for at least 90 days and remains on the same dosing regimen during the study.
• Subject used systemic anti-inflammatory agents\* including aspirin\*\* and non-steroidal anti-inflammatory (NSAIDs) within 3 days prior to Visit 1. (\*Subjects may use Acetaminophen for pain relief, as needed, throughout the study. \*\*Use of low-dose aspirin for cardiac prophylaxis is allowed).
• Subject had immunotherapy (including desensitization therapy to perennial allergens or seasonal allergens not found in the current season) initiated or the subject's dosage or frequency of immunotherapy has been adjusted within the 30 days preceding Visit 1.

Sponsors & Collaborators

• Padagis LLC: lead

Study Sites (1)

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

US (1)