Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation

NCT01523236 | Completed Phase 1

• 1 other identifier: 70936005
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the clinical equivalence of the test formulation of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) to the marketed formulation Nasonex® (mometasone furoate monohydrate) nasal spray, 50 mcg/actuation (Schering) in patients with seasonal allergic rhinitis. In addition, the efficacy of both the test and reference nasal sprays will be compared to a placebo nasal spray and safety will be compared.

Conditions

Seasonal Allergic Rhinitis

Keywords

Allergic Rhinitis; Bioequivalence

Outcome Measures

Primary Outcomes (1)

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

  The statistical analysis for both clinical equivalence and superiority of the active treatments over placebo will involve Analysis of Covariance (ANCOVA). The Per-Protocol Population (PPP) will be used for the primary analysis of bioequivalence. The Intent-to-Treat Population (ITT) will be used for the primary analysis of superiority.

  2 week treatment period

Secondary Outcomes (1)

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

  2 week treatment period

Study Arms (3)

Investigational Test Product

EXPERIMENTAL

Mometasone furoate anhydrous 50 mcg/actuation Nasal Spray (Teva)

Drug: Mometasone furoate

Reference Listed Drug

ACTIVE COMPARATOR

Nasonex® (mometasone furoate monohydrate) 50 mcg/actuation Nasal Spray (Schering)

Drug: Nasonex®

Placebo

PLACEBO COMPARATOR

Saline Placebo Nasal Spray

Drug: Placebo

Interventions

Mometasone furoate DRUG

50 mcg/actuation Nasal Spray

Investigational Test Product

Nasonex® DRUG

50 mcg/actuation Nasal Spray

Also known as: Mometasone furoate (generic name)

Reference Listed Drug

Placebo DRUG

Nasal Spray

Placebo

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:

• Male or non-pregnant, non-lactating female 12 years or age or older.
• Signed informed consent form, which meets all criteria of current FDA regulations. For patients under the age of majority in the state the study is being conducted (18 years in most states) the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form that will be written in such a way as to be understandable to a child.
• If female and of child-bearing potential, have a negative urine pregnancy test and is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study. In order for hormonal birth control to be considered a reliable method the patient must have been on their regimen for at least 28 days.
• Documented positive allergic skin test, performed within the previous 12 months, to one or more of the allergens in season at the time the study is being conducted.
• A minimum of two years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
• A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) and a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms. The patient must meet these minimum requirements prior to being entered into the placebo lead-in period and also prior to being enrolled in the randomized, active treatment period of the study.

You may not qualify if:

• Under 12 years of age.
• Females who are pregnant, lactating, or likely to become pregnant during the study.
• Negative or lack of documented skin allergen test (performed within the previous 12 months) to at least one of the allergens in season at the time the study is being conducted. The results of all positive skin allergen test results should be reported.
• 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.
• Patients who suffer only from perennial allergic rhinitis of seasonal allergic rhinitis to a different allergen than that in season at the time the study in conducted.
• Previous history of less that 2 years of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
• A total score of less than 6 on the reflective Total Nasal Symptom Score (rTNSS) or a score less than 2 for "nasal congestion" or a score less than 2 for all 3 remaining symptoms. Any patient who meets the minimum rTNSS requirements at the start of the placebo lead-in period but no longer meets the requirements prior to the randomized active treatment period of the study cannot continue in the active treatment period.
• History of asthma over the previous two years that required chronic therapy. Occasional acute or mild exercise induced asthma will be allowable on the condition that the treatment of the attacks is restricted to beta-agonists only.
• Patients with nasal conditions, including infectious rhinitis, rhinitis medicamentosa, or atrophic rhinitis.
• Clinically significant nasal deformity (e.g. significantly deformed septum, nasal polyps or ulcers) or any recent nasal surgery or trauma that has not completely healed.
• Sinus infection within the previous 30 days or history of re-occurring sinus infections.
• Patient has started immunotherapy (including topical or desensitization therapy) or changed their dose of immunotherapy within 30 days of the first placebo lead-in dose, or is likely to have to start immunotherapy or change their current dose during the study.
• Treatment for oral Candidiasis within 30 days of starting the study or a current oral Candidiasis infection.
• Upper respiratory tract infection within the previous 30 days.
• Patients with a history of tuberculosis.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; 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 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 1, 2012
• Study Start: December 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 1, 2012

Record last verified: 2012-01