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
  Purpose

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.


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: Double Blind (Subject, Caregiver, 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 Inc.:

Primary Outcome Measures:
  • The mean change from baseline for mean rTNSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The mean change from baseline for mean iTNSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 962
Study Start Date: December 2010
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Inc.
  More Information

No publications provided

Responsible Party: Sandoz Inc.
ClinicalTrials.gov Identifier: NCT01279057     History of Changes
Other Study ID Numbers: 71047201, Lek Project Number: 2010-02
Study First Received: January 17, 2011
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Signs and Symptoms
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 28, 2014