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

Completed · Phase 3 · Has a placebo group

Conditions studied: Rhinitis, Allergic, Seasonal

In brief

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.

Key facts

Study ID

NCT01279057

Run by

Sandoz

People needed

727

Starts

2010-12-27

Expected to finish

2011-02-08

Last updated by the study team

2021-02-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Sandoz Investigational Site — Austin, Texas, United States
• Sandoz Investigational Site — Austin, Texas, United States
• Sandoz Investigational Site — Austin, Texas, United States
• Sandoz Investigational Site — Kerrville, Texas, United States
• Sandoz Investigational Site — New Braunfels, Texas, United States
• Sandoz Investigational Site — San Antonio, Texas, United States
• Sandoz Investigational Site — Waco, Texas, United States

Full record on ClinicalTrials.gov

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