Last updated: 11/07/2018 16:44:57
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)
EudraCT ID
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 6 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:
Not applicable
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline (Day 1) over the entire treatment period in daily, reflective total nasal symptom scores (rTNSS) over 6 weeks
Timeframe: Baseline (Day 1) and up to Week 6
Secondary outcomes:
Mean change from Baseline (Day 1) in AM, pre-dose, instantaneous total nasal symptom (iTNSS) scores over the entire treatment period
Timeframe: Baseline (Day 1) and up to Week 6
Number of participants with response to therapy over entire treatment period
Timeframe: Up to 6 weeks
Mean change from Baseline (Day 1) in AM rTNSS over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in PM rTNSS over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean percent change from Baseline (Day 1) in Daily rTNSS over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean percent change from Baseline (Day 1) in AM Pre-Dose iTNSS over the entire treatment period
Timeframe: Baseline and up to 6 weeks
Mean change from Baseline (Day 1) in daily reflective individual nasal symptom scores (rINSS) over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in AM pre-dose instantaneous individual nasal symptom score (iINSS) over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in AM rINSS over the entire treatment
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in PM rINSS over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in daily reflective total ocular symptom score (rTOSS) over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in AM pre-dose instantaneous TOSS (iTOSS) over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean Change from Baseline (Day 1) in AM rTOSS over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in PM rTOSS over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in daily reflective individual ocular symptom scores (iIOSS) over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in AM Pre-Dose instantaneous individual ocular symptom score (iIOSS) over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in AM reflective individual ocular symptom score (rIOSS) over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in PM rIOSS over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in daily peak nasal inspiratory flow (PNIF) over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in AM PNIF over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Mean change from Baseline (Day 1) in PM PNIF over the entire treatment period
Timeframe: Baseline (Day 1) and up to 6 weeks
Interventions:
Drug: FF
Drug: Placebo
Enrollment:
301
Observational study model:
Not applicable
Primary completion date:
2006-04-07
Time perspective:
Not applicable
Clinical publications:
Maire Vasar, Pierre-Alain Houle, Jo Anne Douglass, Eli Meltzer, MaryJane Silvey, Wei Wu, Mark Caldwell, Edward Philpot. Fluticasone furoate nasal spray: Effective monotherapy for symptoms of perennial allergic rhinitis in adults/adolescents. Allergy and Asthma Proceedings. 2008;29:313–321.
Meltzer E, Vasar M, Houle P, Douglass J, Silvey M, Wu W, Philpot E, Caldwell M. Fluticasone furoate nasal spray provides 24-hour relief of perennial allergic rhinitis symptoms. Ann Allergy Asthma Immunol. 2008;100(1 Suppl 1):A4.
Vasar M, Houle P, Douglass J, Meltzer E, Silvey M, Wu W, Caldwell M, Philpot E. A novel enhanced-affinity corticosteroid, once daily fluticasone furoate nasal spray (FFNS), provides 24-hour relief for the nasal symptoms of perennial allergic rhinitis (PAR). Allergy. 2007;62(Suppl 83):227
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)
February 2006 to July 2006
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 and other identified medications during the study.
- Current tobacco use or tobacco use within the past year.
- Exposure to an investigational study drug within the past 12 months.
- Clinically significant abnormal electrocardiograms (ECG) or laboratory abnormality.
Trial location(s)
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02906
Status
Study Complete
Location
GSK Investigational Site
Toorak Gardens, South Australia, Australia, 5065
Status
Study Complete
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Trois Rivieres, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21236
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
Wheaton, Maryland, United States, 20902
Status
Study Complete
Location
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-04-07
Actual study completion date
2006-04-07
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.
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