A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110mcg in Adult and Adolescent Subjects 12 Years of Age and Older With Perennial Allergic Rhinitis (PAR)
1 other identifier
interventional
315
7 countries
37
Brief Summary
The purpose of this study is to compare the effects (effectiveness and safety) of an intranasal corticosteroid (fluticasone furoate nasal spray \[FFNS\]), with a placebo nasal spray for the treatment of perennial (year-round) allergic rhinitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2008
Shorter than P25 for phase_4
37 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
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 24, 2008
CompletedFirst Posted
Study publicly available on registry
February 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
December 23, 2009
CompletedDecember 16, 2016
November 1, 2016
5 months
January 24, 2008
June 22, 2009
November 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)
TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 \[none\] to 3 \[severe\]; total possible score of 0 to 12). The rTNSS (performed in the morning \[AM\] and evening \[PM\]) was a rating of the severity of symptoms over the previous 12 hours. The daily rTNSS was the average of the AM rTNSS and PM rTNSS assessments. Change from baseline is calculated as the score at the end of study minus the score at baseline.
Daily; Baseline through End of Study (Week 4)
Secondary Outcomes (14)
Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS)
Daily; Baseline through End of Study (Week 4)
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS)
Daily; Baseline through End of Study (Week 4)
Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS
Daily; Baseline through End of Study (Week 4)
Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS
Daily; Baseline through End of Study (Week 4)
Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS
Daily; Baseline through End of Study (Week 4)
- +9 more secondary outcomes
Study Arms (2)
fluticasone furoate nasal spray
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects eligible for enrollment in the study must meet all of the following criteria:
- Informed consent
- Subject has provided an appropriately signed and dated informed consent.
- An appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age.
- Outpatient
- Subject is treatable on an outpatient basis.
- Age
- ≥ 12 years at Visit 2
- ≥ 18 years at Visit 1 for Russia and Germany
- 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 performed for all females of childbearing potential at Visits 1, 2, 5, and Visit 6/Early Withdrawal 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,
- +23 more criteria
You may not qualify if:
- Subjects meeting any of the following criteria must not be enrolled in the study:
- 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 double blind intranasal study drug
- nasal (e.g., nasal septum) or ocular injury/surgery in the last 3 months
- asthma, with the exception of mild intermittent asthma \[NAEPP, 2007; GINA, 2006\], or very mild asthma (Canada) \[Lemiére, 2004\].
- NOTE: Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis.
- 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 ocular herpes simplex
- current cataract
- 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
- +39 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (37)
GSK Investigational Site
Baltimore, Maryland, 21236, United States
GSK Investigational Site
Wheaton, Maryland, 20902, United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
Plymouth, Minnesota, 55441, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Lincoln, Nebraska, 68505, United States
GSK Investigational Site
Ocean City, New Jersey, 07712, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Providence, Rhode Island, 02906, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Greenfield, Wisconsin, 53228, United States
GSK Investigational Site
Winnipeg, Manitoba, R2M 5L9, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5, Canada
GSK Investigational Site
Hamilton, Ontario, L8N 3Z5, Canada
GSK Investigational Site
Kanata, Ontario, K2L 3C8, Canada
GSK Investigational Site
Mississauga, Ontario, L5A 3V4, Canada
GSK Investigational Site
Ottawa, Ontario, K1Y 4G2, Canada
GSK Investigational Site
Toronto, Ontario, M9W 4L6, Canada
GSK Investigational Site
Québec, Quebec, G1V 4M6, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Saskatoon, Saskatchewan, S7H 0V1, Canada
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Hanover, Lower Saxony, 30159, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112, Germany
GSK Investigational Site
Berlin, State of Berlin, 10787, Germany
GSK Investigational Site
Budapest, 1015, Hungary
GSK Investigational Site
Budapest, 1116, Hungary
GSK Investigational Site
Budapest, 1148, Hungary
GSK Investigational Site
Budapest, 1204, Hungary
GSK Investigational Site
Moscow, 115478, Russia
GSK Investigational Site
Moscow, 123095, Russia
GSK Investigational Site
Saint Petersburg, 190013, Russia
GSK Investigational Site
Banská Bystrica, 975 17, Slovakia
GSK Investigational Site
Bratislava, 812 50, Slovakia
GSK Investigational Site
Prešov, 080 01, Slovakia
Related Publications (1)
Given JT, Cheema AS, Dreykluft T, Stillerman A, Silvey M, Wu W, Snowise NG, Philpot E. Fluticasone furoate nasal spray is effective and well tolerated for perennial allergic rhinitis in adolescents and adults. Am J Rhinol Allergy. 2010 Nov-Dec;24(6):444-50. doi: 10.2500/ajra.2010.24.3534.
PMID: 21144223BACKGROUND
Related Links
MeSH Terms
Conditions
Condition 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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 7, 2008
Study Start
January 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
December 16, 2016
Results First Posted
December 23, 2009
Record last verified: 2016-11
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.