Rhinitis, Allergic, Perennial Clinical Trial
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
Verified date | January 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.
Status | Completed |
Enrollment | 558 |
Est. completion date | November 2005 |
Est. primary completion date | November 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 12 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Argentina | GSK Investigational Site | Buenos Aires | |
Argentina | GSK Investigational Site | Nueve de Julio | Buenos Aires |
Argentina | GSK Investigational Site | Rosario | Santa Fe |
Argentina | GSK Investigational Site | Santa Fe | |
Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
Chile | GSK Investigational Site | Viña del Mar | Valparaíso |
Finland | GSK Investigational Site | Joensuu | |
Finland | GSK Investigational Site | Nokia | |
Finland | GSK Investigational Site | Tampere | |
Finland | GSK Investigational Site | Turku | |
Italy | GSK Investigational Site | Bari | |
Italy | GSK Investigational Site | Milano | |
Italy | GSK Investigational Site | Monticelli Ascoli Piceno | |
Italy | GSK Investigational Site | Napoli | Campania |
Italy | GSK Investigational Site | Perugia | |
Italy | GSK Investigational Site | Salerno | |
Mexico | GSK Investigational Site | Mexico | |
Mexico | GSK Investigational Site | Mexico | |
Mexico | GSK Investigational Site | Monterrey, N.L | |
Slovakia | GSK Investigational Site | Banska Bystrica | |
Slovakia | GSK Investigational Site | Bratislava | |
Slovakia | GSK Investigational Site | Levoca | |
Slovakia | GSK Investigational Site | Nitra | |
United States | GSK Investigational Site | Baltimore | Maryland |
United States | GSK Investigational Site | Bellevue | Pennsylvania |
United States | GSK Investigational Site | Brick | New Jersey |
United States | GSK Investigational Site | Charleston | South Carolina |
United States | GSK Investigational Site | Cincinnati | Ohio |
United States | GSK Investigational Site | Coral Gables | Florida |
United States | GSK Investigational Site | Costa Mesa | California |
United States | GSK Investigational Site | Cudahy | California |
United States | GSK Investigational Site | Denver | Colorado |
United States | GSK Investigational Site | Denver | Colorado |
United States | GSK Investigational Site | El Paso | Texas |
United States | GSK Investigational Site | Englewood | Colorado |
United States | GSK Investigational Site | Gainesville | Georgia |
United States | GSK Investigational Site | Ithaca | New York |
United States | GSK Investigational Site | Jackson | Mississippi |
United States | GSK Investigational Site | Kansas City | Missouri |
United States | GSK Investigational Site | Knoxville | Tennessee |
United States | GSK Investigational Site | Lake Oswego | Oregon |
United States | GSK Investigational Site | Lawrenceville | Georgia |
United States | GSK Investigational Site | Liverpool | New York |
United States | GSK Investigational Site | Long Beach | California |
United States | GSK Investigational Site | Long Beach | California |
United States | GSK Investigational Site | Medford | Oregon |
United States | GSK Investigational Site | Metairie | Louisiana |
United States | GSK Investigational Site | Nashville | Tennessee |
United States | GSK Investigational Site | Oklahoma City | Oklahoma |
United States | GSK Investigational Site | Omaha | Nebraska |
United States | GSK Investigational Site | Omaha | Nebraska |
United States | GSK Investigational Site | Orange | California |
United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
United States | GSK Investigational Site | Raleigh | North Carolina |
United States | GSK Investigational Site | Riverside | California |
United States | GSK Investigational Site | Rochester | New York |
United States | GSK Investigational Site | Rochester | New York |
United States | GSK Investigational Site | Sacramento | California |
United States | GSK Investigational Site | San Diego | California |
United States | GSK Investigational Site | San Diego | California |
United States | GSK Investigational Site | Shreveport | Louisiana |
United States | GSK Investigational Site | Stockbridge | Georgia |
United States | GSK Investigational Site | Upland | Pennsylvania |
United States | GSK Investigational Site | Utica | New York |
United States | GSK Investigational Site | Walnut Creek | California |
United States | GSK Investigational Site | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Argentina, Chile, Finland, Italy, Mexico, Slovakia,
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).
Máspero 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. — View 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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in daily, reflective total nasal symptom scores after first 4-week treatment period in subjects ages 6 to <12 years. | |||
Secondary | 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. |
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