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.

Sponsor:

Information provided by (Responsible Party):

Sandoz Inc.

ClinicalTrials.gov Identifier:

NCT01279057

First received: January 17, 2011

Last updated: December 14, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 17, 2011
Last Updated Date	December 14, 2012
Start Date ^ICMJE	December 2010
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 18, 2011)	The mean change from baseline for mean rTNSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01279057 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 18, 2011)	The mean change from baseline for mean iTNSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Official Title ^ICMJE	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
Brief Summary	This study will compare the safety and efficacy of a generic fluticasone furoate 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Rhinitis, Allergic, Seasonal Seasonal Allergic Rhinitis Hay Fever
Intervention ^ICMJE	Drug: Fluticasone Furoate (Lek Pharmaceuticals ) Nasal Spray 110 mcg per day Drug: Fluticasone furoate (Veramyst®) nasal spray 110 mcg per day Drug: Placebo nasal spray
Study Arm (s)	Experimental: Fluticasone furoate (Lek Pharmaceuticals) nasal spray Intervention: Drug: Fluticasone Furoate (Lek Pharmaceuticals ) Nasal Spray Active Comparator: Fluticasone furoate (Veramyst®) nasal spray Intervention: Drug: Fluticasone furoate (Veramyst®) nasal spray Placebo Comparator: Placebo nasal spray Intervention: Drug: Placebo nasal spray
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	962
Completion Date	Not Provided
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01279057
Other Study ID Numbers ^ICMJE	71047201, Lek Project Number: 2010-02
Has Data Monitoring Committee	Not Provided
Responsible Party	Sandoz Inc.
Study Sponsor ^ICMJE	Sandoz Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sandoz Inc.
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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