A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
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This study will compare 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 will be tested for superiority against a placebo nasal spray.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Fluticasone Furoate Nasal Spray (Lek Pharmaceuticals) With Veramyst® Nasal Spray (GlaxoSmithKline) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Actual Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Sufficient Symptom Scores.
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.