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

This study has been completed.
Information provided by (Responsible Party):
Sandoz Identifier:
First received: January 17, 2011
Last updated: March 27, 2017
Last verified: March 2017
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.

Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Seasonal Allergic Rhinitis
Hay Fever
Drug: Fluticasone Furoate (Lek Pharmaceuticals ) Nasal Spray
Drug: Fluticasone furoate (Veramyst®) nasal spray
Drug: Placebo nasal spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • The mean change from baseline for mean rTNSS [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • The mean change from baseline for mean iTNSS [ Time Frame: 2 weeks ]

Enrollment: 962
Actual Study Start Date: December 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluticasone furoate (Lek Pharmaceuticals) nasal spray Drug: Fluticasone Furoate (Lek Pharmaceuticals ) Nasal Spray
110 mcg per day
Active Comparator: Fluticasone furoate (Veramyst®) nasal spray Drug: Fluticasone furoate (Veramyst®) nasal spray
110 mcg per day
Placebo Comparator: Placebo nasal spray Drug: Placebo nasal spray


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01279057

United States, Texas
Sandoz Investigational Site
Austin, Texas, United States, 78731/50/
Sandoz Investigational Site
Kerrville, Texas, United States, 78028
Sandoz Investigational Site
New Braunfels, Texas, United States, 78130
Sandoz Investigational Site
San Antonio, Texas, United States, 78229
Sandoz Investigational Site
Waco, Texas, United States, 76712
Sponsors and Collaborators
  More Information

Responsible Party: Sandoz Identifier: NCT01279057     History of Changes
Other Study ID Numbers: 71047201
Lek Project Number: 2010-02
Study First Received: January 17, 2011
Last Updated: March 27, 2017

Keywords provided by Sandoz:
Rhinitis, allergic, seasonal, fluticasone furoate, equivalence

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Signs and Symptoms
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents processed this record on May 25, 2017