A Pilot, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of Once-daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110 mcg for 4 Weeks in Adults and Adolescents With Irritant (Non-Allergic) Rhinitis

GlaxoSmithKline1 site in 1 country102 target enrollmentMarch 2008

ConditionsRhinitis, Allergic, Perennial

InterventionsFluticasone Furoate Nasal Spray Placebo Nasal Spray

Overview

Phase: Phase 2
Intervention: Fluticasone Furoate Nasal Spray
Conditions: Rhinitis, Allergic, Perennial
Sponsor: GlaxoSmithKline
Enrollment: 102
Locations: 1
Primary Endpoint: Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this pilot 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 irritant (non-allergic) rhinitis.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

February 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Informed consent: Subject is willing and able to provide consent to participate in the study. For subjects who are under 18 years of age, an appropriately signed and dated assent must be obtained from the parents or guardian.
•Outpatient: Subject is treatable on an outpatient basis.
•Age: 12 years of age or older at Visit
•Gender: Male or eligible female
•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:
•Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
•Implants of levonorgestrel
•Injectable progestogen
•Oral contraceptive (either combined estrogen/progestin or progestin only)
•Any intrauterine device (IUD) with a documented failure rate of less than 1% per year, or

Exclusion Criteria

•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 \[Global Initiative for Asthma (GINA), 2006\]. 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 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 a sinus radiograph (Waters view) done at Visit 1
•current or history of glaucoma and/or current cataract or ocular herpes simplex
•physical impairment that would affect the subject's ability to participate in the study

Arms & Interventions

Arm A

Fluticasone Furoate Nasal Spray 110mcg intranasally once daily

Intervention: Fluticasone Furoate Nasal Spray

Arm B

Matching placebo nasal spray intranasally once daily

Intervention: Placebo Nasal Spray

Outcomes

Primary Outcomes

Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days)

Time Frame: Baseline through Week 4 (28 days)

The Total Nasal Symptom Score (TNSS) is the sum (scale 0-9) of the individual nasal scores for rhinorrhea, nasal congestion, and post-nasal drip. All symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours. The daily reflective Total Nasal Symptoms Score (daily rTNSS) is the average of the AM and PM rTNSS. Mean change from baseline was calculated as the participant's treatment period mean minus the baseline mean.

Secondary Outcomes

Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days)(Baseline through Week 4 (28 days))
Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days)(Baseline through Week 4 (28 days))
Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)(Baseline through Week 4 (28 days))
Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)(Baseline through Week 4 (28 days))
Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days)(Baseline through Week 4 (28 days))
Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)(Baseline through Week 4 (28 days))
Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)(Baseline through Week 4 (28 days))
Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)(Baseline through Week 4 (28 days))