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)

GlaxoSmithKline Research & Development Ltd0 sites288 target enrollmentFebruary 11, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Perennial Allergic Rhinitis (PAR) in adults and children of 12 years and older.
Sponsor: GlaxoSmithKline Research & Development Ltd
Enrollment: 288
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

February 11, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects eligible for enrollment in the study must meet all of the following criteria:
•1\. 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.
•2\. Outpatient
•Subject is treatable on an outpatient basis.
•\>\= 12 years at Visit 2
•\>\= 18 years at Visit 1 for Russia and Germany
•4\. 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.

•1\. 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
•current or history of glaucoma and/or ocular herpes simplex