Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS
A Randomized, Double-blind, Placebo-controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy and Patient Preference of Nasal Spray Characteristics of Once-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects With Seasonal Allergic Rhinitis
1 other identifier
interventional
360
1 country
28
Brief Summary
The purpose of this replicate study to FFU105924 is to provide data on subject preference of FFNS as compared with FPNS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2007
Shorter than P25 for phase_4
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 21, 2007
CompletedFirst Posted
Study publicly available on registry
August 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
January 15, 2010
CompletedDecember 9, 2016
October 1, 2016
3 months
August 21, 2007
November 7, 2008
October 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.
Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Subjects assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Subject could also choose "I have no preference."
End of Crossover Period (Day 22)
Secondary Outcomes (5)
Comparation of Mean Change From Baseline Over Each Treatment Period in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos
Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Comparision of Mean Change From Baseline Over Each Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos
Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat
End of Crossover Period (Day 22)
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use
End of Crossover Period (Day 22)
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist
End of Crossover Period (Day 22)
Study Arms (4)
FFNS, FPNS
ACTIVE COMPARATORfluticasone furoate nasal spray, fluticasone propionate nasal spray
FPNS, FFNS
ACTIVE COMPARATORfluticasone propionate nasal spray, fluticasone furoate nasal spray
placebo FFNS, placebo FPNS
PLACEBO COMPARATORplacebo nasal spray matching fluticasone furoate nasal spray, placebo nasal spray matching fluticasone propionate nasal spray
placebo FPNS, placebo FFNS
PLACEBO COMPARATORplacebo nasal spray matching fluticasone propionate nasal spray, placebo nasal spray matching fluticasone furoate nasal spray
Interventions
fluticasone propionate nasal spray
placebo nasal spray matching fluticasone furoate nasal spray
placebo nasal spray matching fluticasone propionate nasal spray
Eligibility Criteria
You may qualify if:
- Informed consent
- Subject has provided an appropriately signed and dated informed consent.
- Otherwise healthy outpatient with fall allergy
- Subject is treatable on an outpatient basis.
- Age
- years or age or older at time of Visit 2
- Male or eligible female
- Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be required of all females at all visits to determine if the subject is pregnant.
- To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
- Abstinence
- Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
- Oral contraceptive (either combined estrogen/progestin or progestin only)
- Injectable progestogen
- Implants of levonorgestrel
- Percutaneous contraceptive patches
- +18 more criteria
You may not qualify if:
- Recent use (less than 1 year) of using branded (FLONASE) or generic FPNS or use of FFNS (VERAMYST).
- Significant concomitant medical conditions, defined as but not limited to:
- A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
- A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of intranasal study drug
- Nasal (eg, nasal septum) injury or surgery in the last 3 months
- Asthma, with the exception of mild intermittent asthma \[National Asthma Education and Prevention Program (NARPP) Guidelines, 2002\].
- Rhinitis medicamentosa
- Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period
- Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
- Current or history of glaucoma and/or cataracts or ocular herpes simplex Physical impairment that would affect subject's ability to participate safely and fully in the study
- Clinical evidence of a Candida infection of the nose
- History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results
- History of adrenal insufficiency
- History of shingles
- Chickenpox or measles: A subject is not eligible if he/she currently has chickenpox or measles, or has been exposed to chickenpox or measles during the last 3 weeks and is non-immune. If a subject develops chickenpox or measles during the study, he/she will be withdrawn from the study. If a non-immune subject is exposed to chickenpox or measles during the study, his/her continuation in the study will be at the discretion of the investigator, taking into consideration the likelihood of developing active disease.
- +32 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (28)
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Los Angeles, California, 90025, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
San Francisco, California, 94104, United States
GSK Investigational Site
San Jose, California, 95117, United States
GSK Investigational Site
Vista, California, 92083, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Lilburn, Georgia, 30047, United States
GSK Investigational Site
Bangor, Maine, 04401, United States
GSK Investigational Site
Bethesda, Maryland, 20814, United States
GSK Investigational Site
Ocean City, New Jersey, 07712, United States
GSK Investigational Site
Ithaca, New York, 14850, United States
GSK Investigational Site
Rockville Centre, New York, 11570, United States
GSK Investigational Site
Collegeville, Pennsylvania, 19426, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19115, United States
GSK Investigational Site
Charleston, South Carolina, 29406, United States
GSK Investigational Site
Austin, Texas, 78731, United States
GSK Investigational Site
Austin, Texas, 78750, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
El Paso, Texas, 79925, United States
GSK Investigational Site
New Braunfels, Texas, 78130, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
Related Publications (1)
Meltzer EO, Andrews C, Journeay GE, Lim J, Prillaman BA, Garris C, Philpot E. Comparison of patient preference for sensory attributes of fluticasone furoate or fluticasone propionate in adults with seasonal allergic rhinitis: a randomized, placebo-controlled, double-blind study. Ann Allergy Asthma Immunol. 2010 Apr;104(4):331-8. doi: 10.1016/j.anai.2010.02.010.
PMID: 20408344BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2007
First Posted
August 22, 2007
Study Start
August 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
December 9, 2016
Results First Posted
January 15, 2010
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.