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

Status:	Completed
Conditions:	Allergy
Therapuetic Areas:	Otolaryngology
Healthy:	No
Age Range:	12 - Any
Updated:	3/29/2017
Start Date:	December 2010
End Date:	February 2011

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

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.

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.

- Sufficient Symptom Scores.

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.

We found this trial at

sites

Sandoz Investigational Site

Kerrville, Texas 78028

from

Kerrville, TX