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
Condition: Rhinitis, Allergic, Perennial; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: fluticasone furoate nasal spray; placebo
Intervention description: fluticasone furoate nasal spray 110ug, once daily; placebo
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 365.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: safety; efficacy; placebo; allergic rhinitis; fluticasone furoate

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 as AR. There are 3 phases, 2 to14 day run in, 2 week treatment, and 3 to 5
      day follow up. After run in period, at least 360 subjects with AR ( ages of 12yrs and 65yrs,
      inclusive) will be randomised to receive FFNS 110ug once daily or placebo for 2 weeks. The
      primary endpoint is the change from baseline of reflective total nasal symptom score (rTNSS)
      during treatment period, and the secondary endpoints include mean change from baseline in
      nasal finding scores by rhinoscopy at completion of study treatment, and severity of overall
      inference in activities of daily living. Safety measures include AE (Adverse Event) reports,
      ECGs (Electrocardiograph), physical exams, vital signs, and nasal exam. In addition,
      reflective total ocular symptom score (rTOSS) will be measured as an explorative endpoint,
      only in the specific AR (Allergic Rhinitis) patients with severe ocular symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects can be enrolled when meeting all criteria as below.

               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

        Exclusion Criteria:

          -  Subjects should be excluded when meeting one of criteria as below.

               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.

                    1. allergy medications

                    2. other medications that may affect allergic rhinitis or its symptoms

                    3. any medications that significantly inhibit CYP3A4, including ritonavir and
                       ketoconazole