Rhinitis, Allergic, Perennial
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, Chinese adolescent and adult (male or eligible female) outpatients with the age of >=12 years 2, 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) 3, Subject must be symptomatic at screening and willing to maintain same environment throughout the study 4, Ability to comply with study procedures 5, Literate Are the trial subjects under 18? yes Number of subjects for this age range: 19 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 344 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Having complications of nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis 2. Having complications of bacterial/viral infection of upper respiratory tract 3. Having significant systemic diseases 4. History of hypersensitivity to steroids and ingredients 5. Pregnant women or under lactation 6. Patients who started, discontinued or changed dose of desensitization therapy within 30 days before visit 1 7. Patients planning to travel outside the region 8. Patients judged to be inappropriate by investigators 9. Patients who participated in another study within 4 months before screening 10. Patients who could not withdraw drugs during screening period or secure withdrawal period until the initiation day of administration, e.g. a) allergy medications b) other medications that may affect allergic rhinitis or its symptoms c) any medications that significantly inhibit CYP3A4, including ritonavir and ketoconazole
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - At completion of study treatment, the mean change from baseline in severity of overall inference in activities of dairy living - At completion of study treatment, mean change from baseline in nasal finding scores by rhinoscopy ;Timepoint(s) of evaluation of this end point: 2 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety of Fluticasone Furoate Nasal Spray 110µg once daily with vehicle placebo nasal spray for 2 weeks in Chinese adult and adolescent subjects with Allergic Rhinitis;Secondary Objective: Not applicable;Primary end point(s): The mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom score (rTNSS);Timepoint(s) of evaluation of this end point: 2 weeks | — |
Countries
China
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed