Clinical trial NCT00108914: Perennial Allergic Rhinitis Study In Pediatric Subjects
Official title: A Two Week Randomized, Double Blind Placebo Controlled, Parallel Group Study of GW685698X Aqueous Nasal Spray 100mcg and 50mcg QD in Pediatric Subjects With Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Keywords: Perennial allergic rhinitis
pediatric
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-04-21
Enrollment: 558
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.

Detailed description: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to \<12 Years with Perennial Allergic Rhinitis (PAR)

Eligibility criteria: Inclusion criteria:

* Diagnosis of perennial allergic rhinitis.

Exclusion criteria:

* Have significant concomitant medical conditions.
* Use of corticosteroids or other allergy medications during the study.
* Have abnormal ECG.
* Have laboratory abnormality.
* Have abnormal eye exam.

Primary outcomes:
measure: Improvement in daily, reflective total nasal symptom scores after first 4-week treatment period in subjects ages 6 to <12 years.
Secondary outcomes:
measure: Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period for subjects ages 6 to <12 years.
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: GSK Investigational Site
state: California
city: Cudahy
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Orange
country: United States
facility: GSK Investigational Site
state: California
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Englewood
country: United States
facility: GSK Investigational Site
state: Colorado
city: Coral Gables
country: United States
facility: GSK Investigational Site
state: Florida
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Stockbridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Ypsilanti
country: United States
facility: GSK Investigational Site
state: Michigan
city: Jackson
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Brick
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Ithaca
country: United States
facility: GSK Investigational Site
state: New York
city: Liverpool
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Utica
country: United States
facility: GSK Investigational Site
state: New York
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Lake Oswego
country: United States
facility: GSK Investigational Site
state: Oregon
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Bellevue
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Upland
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: El Paso
country: United States
facility: GSK Investigational Site
state: Texas
city: Nueve de Julio
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: GSK Investigational Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Santa Fe
country: Argentina
facility: GSK Investigational Site
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Viña del Mar
country: Chile
facility: GSK Investigational Site
state: Valparaíso
city: Joensuu
country: Finland
facility: GSK Investigational Site
city: Nokia
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Bari
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Monticelli Ascoli Piceno
country: Italy
facility: GSK Investigational Site
city: Perugia
country: Italy
facility: GSK Investigational Site
city: Salerno
country: Italy
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Monterrey, N.L
country: Mexico
facility: GSK Investigational Site
city: Banska Bystrica
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Levoca
country: Slovakia
facility: GSK Investigational Site
city: Nitra
country: Slovakia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Máspero J, Rosenblut A, Finn A, J Lim J, Wu W, Philpot E. Safety of fluticasone furoate* nasal spray in children with perennial allergic rhinitis (*USAN approved name). Allergy 2007;62(Suppl. 83): 381 (abstract).
citation: Máspero JF, Rosenblut A, Finn A, Lim J, Wu W, Faris M, Philpot E. Once-daily fluticasone furoate nasal spray (FF) is safe and effective in the long-term treatment of perennial allergic rhinitis (PAR) in children ages 2 to 11 years. J Allergy Clin Immunol.
citation: Maspero JF, Rosenblut A, Finn A Jr, Lim J, Wu W, Philpot E. Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis. Otolaryngol Head Neck Surg. 2008 Jan;138(1):30-7. doi: 10.1016/j.otohns.2007.10.023.