Last updated: 11/04/2018 07:00:22
A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)
Trial description: The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms.
Timeframe: N/A
Secondary outcomes:
Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit.
Timeframe: N/A
Interventions:
Drug: GW685698X
Enrollment:
288
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Nathan R, Berger W, Yang W, Cheema A, Silvey MJ, Wu W, Faris M, Philpot E. Once daily fluticasone furoate* nasal spray (FFNS), a novel enhanced affinity steroid, provides 24-hour relief for the nasal symptoms of perennial allergic rhinitis (PAR) J Allergy
Robert A Nathan, William Berger, William Yang, Amarjit Cheema, Mary Jane Silvey, Wei Wu, Edward Philpot. Effect of once-daily fluticasone furoate nasal spray relieves nasal symptoms in adults and adolescents with perennial allergic rhinitis . Ann Allergy Asthma Immunol. 2008;100(5):497-505.
Wu W1 Walters RD, Nadeau GA, Botnick W, Broughton N. An integrated analysis of the efficacy of fluticasone furoate nasal spray versus placebo on the individual symptoms of perennial allergic rhinitis. Allergy Asthma Proc. 2013;34(3):283-91.
Medical condition
Rhinitis, Allergic, Perennial
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
January 2005 to May 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Diagnosis of perennial allergic rhinitis (PAR).
- Must comply with study procedures and be literate.
- Significant concomitant medical conditions.
- Use of corticosteroids.
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of perennial allergic rhinitis (PAR).
- Must comply with study procedures and be literate.
Exclusion criteria:
- Significant concomitant medical conditions.
- Use of corticosteroids.
- Use of allergy medications and some other medications during the study.
- Current tobacco use.
- Clinically significant abnormal ECG or laboratory abnormality.
Trial location(s)
Location
GSK Investigational Site
Ocean, New Jersey, United States, 07712
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02906
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Study Complete
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7H 0V1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21236
Status
Study Complete
Location
GSK Investigational Site
New Braunfels, Texas, United States, 78130
Status
Study Complete
Location
GSK Investigational Site
Vero Beach, Florida, United States, 32960
Status
Study Complete
Location
GSK Investigational Site
North Andover, Massachusetts, United States, 01845
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E1
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 9L8
Status
Study Complete
Location
GSK Investigational Site
Lilburn, Georgia, United States, 30047
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90025
Status
Study Complete
Location
GSK Investigational Site
West Allis, Wisconsin, United States, 53227
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203-1424
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Study Complete
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63104
Status
Study Complete
Location
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46617
Status
Study Complete
Location
GSK Investigational Site
Summit, New Jersey, United States, 07091
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rockville, Maryland, United States, 20850
Status
Study Complete
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68505
Status
Study Complete
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-02-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website