A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

727 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-27

Study Completion Date

2011-02-08

Brief Summary

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This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

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Detailed Description

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The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of fluticasone furoate, 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Veramyst® nasal spray (GlaxoSmithKline) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 110 mcg was 4 actuations, each containing 27.5 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.

Conditions

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Rhinitis, Allergic, Seasonal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test

Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.

Group Type EXPERIMENTAL

Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals)

Intervention Type DRUG

Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.

Reference

Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.

Group Type ACTIVE_COMPARATOR

Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray

Intervention Type DRUG

Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.

Placebo

Placebo nasal spray administered once daily for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo nasal spray administered once daily (4 actuations) for 14 days.

Interventions

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Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals)

Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.

Intervention Type DRUG

Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray

Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.

Intervention Type DRUG

Placebo

Placebo nasal spray administered once daily (4 actuations) for 14 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of 2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
* Signed informed consent (assent) form.
* Documented positive allergic skin test to local pollen.
* An average score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum score of at least 2 for "nasal congestion" and at least 4 on the reflective Total Ocular Symptom Score (rTOSS).

Exclusion Criteria

* History of asthma that required chronic therapy (with the exception of occasional acute or mild exercise induced asthma).
* Some other past and concomitant medical conditions, prohibited medications.
* Upper respiratory tract infection or any untreated infections.
* Patient has started immunotherapy/changed the dose.
* Any known allergy to any of the components of the study nasal spray.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No