A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Nasal Spray, 50 mcg With Flonase® Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Overview
- Phase
- Phase 3
- Intervention
- Fluticasone propionate
- Conditions
- Seasonal Allergic Rhinitis
- Sponsor
- Teva Pharmaceuticals USA
- Enrollment
- 1474
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14.
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray, 50 mcg (Teva Pharmaceuticals USA) to the FDA Reference Listed Drug, Flonase® (fluticasone propionate) 50 mcg nasal spray (GlaxoSmithKline), in the relief of the signs and symptoms of Seasonal Allergic Rhinitis. Additionally, both the test and reference formulations will be tested for superiority against a placebo nasal spray.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 consecutive 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 representing the 12 hours prior to the screening visit.
- •An average composite 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 representing the last 3 days of the 7-day lead-in period before the randomization visit and the morning of the first day of the randomization visit.
Exclusion Criteria
- •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 of the study is being conducted. The results of all positive shin allergen tests 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 or seasonal allergic rhinitis to a different allergen that that in season at the time the study is conducted.
- •Previous history of less than 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 that 6 on the reflective Total Nasal Symptom Score (rTNSS) or a score of less than 2 for "nasal congestion" or a score of less than 2 for all 3 of the remaining symptoms.
- •History of asthma over the previous 2 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.
Arms & Interventions
Investigational Test Product
Fluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days
Intervention: Fluticasone propionate
Reference Listed Drug
Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days
Intervention: Flonase®
Placebo
Saline Placebo Nasal Spray; 4 total sprays/day for 14 days
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14.
Time Frame: 2 week treatment period: Day 0-14
Total Nasal Symptom Score (TNSS) is defined as the sum of the patient-rated nasal symptom severity scores for the following four allergy symptoms: Runny Nose, Nasal Congestion, Itchy Nose, and Sneezing. The severity score for each symptom will be based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The higher the score, the worse the symptoms of the 4 allergy categories are (runny nose, nasal congestions, itchy nose, and sneezing. The primary analysis for determining the therapeutic equivalence of the Test and Reference treatments will be based on each treatment's mean change from baseline for average rTNSS over the 2 week randomization treatment period. The Per-Protocol Population (PPP) will be used for the primary analysis of bioequivalence. The Modified Intent to Treat Population (mITT) will be used for Superiority Analysis.
Secondary Outcomes
- Change From Baseline in Average Instantaneous Total Nasal Symptom Score (iTNSS) Over Days 1 to 14.(2 week treatment period: Day 0 to Day 14)