Status:
COMPLETED
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rhinitis, Allergic, Perennial
Allergic Rhinitis
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
Brief Summary
The objective of this study is to compare the efficacy and safety of Fluticasone Furoate Nasal Spray (FFNS), that is FFNS with placebo in Chinese adult and adolescent subjects with Allergic Rhinitis a...
Detailed Description
This is a multicenter, 2 week, double blind, randomized, placebo controlled trial. 7 investigational sites will be enlisted to randomize at least 360 subjects (outpatients) during 2009 and 2010. Throu...
Eligibility Criteria
Inclusion
- Subjects can be enrolled when meeting all criteria as below.
- Chinese adolescent and adult (male or eligible female) outpatients with the age of \>=12 years
- Confirmative diagnosis of IAR or PER (as definitions from ARIA 2008 and the coming effective Chinese AR management guideline ), by medical history, symptoms, skin prick tests (SPTs)
- Subject must be symptomatic at screening and willing to maintain same environment throughout the study
- Ability to comply with study procedures
- Literate
Exclusion
- Subjects should be excluded when meeting one of criteria as below.
- Having complications of nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis
- Having complications of bacterial/viral infection of upper respiratory tract
- Having significant systemic diseases
- History of hypersensitivity to steroids and ingredients
- Pregnant women or under lactation
- Patients who started, discontinued or changed dose of desensitization therapy within 30 days before visit 1
- Patients planning to travel outside the region
- Patients judged to be inappropriate by investigators
- Patients who participated in another study within 4 months before screening
- Patients who could not withdraw drugs during screening period or secure withdrawal period until the initiation day of administration, e.g.
- allergy medications
- other medications that may affect allergic rhinitis or its symptoms
- any medications that significantly inhibit CYP3A4, including ritonavir and ketoconazole
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT01231464
Start Date
September 1 2009
End Date
July 1 2010
Last Update
July 6 2017
Active Locations (7)
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1
GSK Investigational Site
Nanjing, Jiangsu, China, 210029
2
GSK Investigational Site
Chengdu, Sichuan, China, 610041
3
GSK Investigational Site
Hangzhou, Zhejiang, China, 310003
4
GSK Investigational Site
Beijing, China, 100730