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)

GlaxoSmithKline1 site in 1 country315 target enrollmentJanuary 2008

ConditionsRhinitis, Allergic, Perennial

InterventionsFluticasone furoate nasal spray Placebo

DrugsFluticasone furoate nasal spray Placebo

Overview

Phase: Phase 4
Intervention: Fluticasone furoate nasal spray
Conditions: Rhinitis, Allergic, Perennial
Sponsor: GlaxoSmithKline
Enrollment: 315
Locations: 1
Primary Endpoint: Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

June 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•≥ 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:

Exclusion Criteria

•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

Arms & Interventions

fluticasone furoate nasal spray

Intervention: Fluticasone furoate nasal spray

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)

Time Frame: Daily; Baseline through End of Study (Week 4)

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.

Secondary Outcomes

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))
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))
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(Daily; Baseline through End of Study (Week 4))
Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)(Daily; Baseline through End of Study (Week 4))
Total Ocular Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Both the Daily rTOSS and the AM, Pre-dose iTOSS(Daily; Baseline through End of Study (Week 4))
Mean Change From Baseline Over the Entire Treatment Period in Both the Individual AM Reflective and PM Reflective Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness(Daily; Baseline through End of Study (Week 4))
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.(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 Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the AM Reflective Total Ocular Symptom Scores (rTOSS) and PM rTOSS(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))
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.(Daily; Baseline through End of Study (Week 4))
Peak Nasal Inspiratory Flow (PNIF): Mean Change From Baseline in Daily, AM, and PM PNIF(Daily; Baseline through End of Study (Week 4))
Mean Change From Baseline to Endpoint in the Rhinoconjunctivitis Quality of Life Questionnaire With Standardised Activities (RQLQ[S])(Baseline and Week 4)