Comparator Study Evaluating Patient 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
377
1 country
24
Brief Summary
The purpose of this replicate study to FFU105927 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
24 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
October 2, 2007
CompletedFirst Posted
Study publicly available on registry
October 3, 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
September 30, 2009
CompletedDecember 9, 2016
October 1, 2016
3 months
October 2, 2007
November 14, 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 Treatment Periods 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)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Participants 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. Participant could also choose "I have no preference."
End of Crossover Period (Day 22)
Secondary Outcomes (5)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat
End of Crossover Period (Day 22)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use
End of Crossover Period (Day 22)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist
End of Crossover Period (Day 22)
Comparision of Mean Change From Baseline Over Treatment Periods 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 Treatment Periods 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)
Study Arms (4)
FFNS, FPNS
ACTIVE COMPARATORactive compound
FPNS, FFNS
ACTIVE COMPARATORactive compound
placebo FFNS, placebo FPNS
PLACEBO COMPARATORplacebo arm
placebo FPNS, placebo FFNS
PLACEBO COMPARATORplacebo arm
Interventions
fluticasone propionate nasal spray
placebo nasal spray matching fluticasone propionate nasal spray
placebo nasal spray matching fluticasone furoate 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
- +33 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (24)
GSK Investigational Site
Scottsdale, Arizona, 85251, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Miami, Florida, 33176, United States
GSK Investigational Site
Baltimore, Maryland, 21236, United States
GSK Investigational Site
North Andover, Massachusetts, 01845, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
Brick, New Jersey, 8724, United States
GSK Investigational Site
Skillman, New Jersey, 08558, United States
GSK Investigational Site
Rochester, New York, 14618, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Charleston, South Carolina, 29414, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
GSK Investigational Site
Johnson City, Tennessee, 37601, United States
GSK Investigational Site
Corsicana, Texas, 75110, United States
GSK Investigational Site
El Paso, Texas, 79902, United States
GSK Investigational Site
Houston, Texas, 77070, United States
GSK Investigational Site
Kerrville, Texas, 78028, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
South Burlington, Vermont, 05403, 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
- Restrictive Agreement
- No
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
October 2, 2007
First Posted
October 3, 2007
Study Start
August 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
December 9, 2016
Results First Posted
September 30, 2009
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.