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

• Status: Completed
• Trial end date: 2011-02-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Treatments: Fluticasone; Xhance

Criteria

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.