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

January 17, 2011
December 14, 2012
December 2010
February 2011   (final data collection date for primary outcome measure)
The mean change from baseline for mean rTNSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01279057 on ClinicalTrials.gov Archive Site
The mean change from baseline for mean iTNSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Rhinitis, Allergic, Seasonal
  • Seasonal Allergic Rhinitis
  • Hay Fever
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
962
Not Provided
February 2011   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01279057
71047201, Lek Project Number: 2010-02
Not Provided
Sandoz Inc.
Sandoz Inc.
Not Provided
Not Provided
Sandoz Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP