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Corticosteroid
A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis
Phase 4
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 4
Awards & highlights
Drug Has Already Been Approved
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
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.
Eligible Conditions
- Allergic Rhinitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)
Secondary study objectives
Individual Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Individual Daily Reflective Nasal Symptom Scores and AM, Pre-dose Instantaneous Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing
Individual Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the Individual, Daily Reflective and the AM, Pre-dose Instantaneous Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness.
Mean Change From Baseline Over the Entire Treatment Period in Both Individual AM Reflective and PM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing.
+11 moreSide effects data
From 2011 Phase 4 trial • 474 Patients • NCT0057049216%
Nasopharyngitis
14%
Bronchitis
9%
Pyrexia
7%
Epistaxis
6%
Cough
6%
Influenza
5%
Pharyngitis
5%
Respiratory Tract Infection Viral
5%
Sinusitis
5%
Upper Respiratory Tract Infection
4%
Gastroenteritis
3%
Asthma
3%
Headache
3%
Tonsillitis
1%
Gastroenteritis Viral
1%
Acute Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
FFNS 110 mcg
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: fluticasone furoate nasal sprayExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluticasone furoate
FDA approved
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,384,255 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,608 Previous Clinical Trials
6,145,149 Total Patients Enrolled