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

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ClinicalTrials.gov Identifier: NCT01279057
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 962 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Actual Study Start Date : December 2010
Primary Completion Date : February 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279057


Locations
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
Sandoz
More Information

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01279057     History of Changes
Other Study ID Numbers: 71047201
Lek Project Number: 2010-02
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

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

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Signs and Symptoms
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
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