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
Study type: Interventional
Phase: Phase 3

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.
    

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. Throughout the entire study period, no antiallergy drugs and rhinitis
      medication, including rescue medication for symptom relief and anti-hyperactivity will be
      allowed. The run in period will consist of a minimum of 2 days and a maximum of 14 days.
      During this period, intermittent allergic rhinitis(IAR) or persistent allergic rhinitis(PER)
      should be diagnosed confirmatively as the definition from the current ARIA (Allergic Rhinitis
      and its Impact on Asthma) guideline and the coming effective Chinese allergic rhinitis
      management guideline. Subjects will assess their nasal symptom scores and compliance in dairy
      cards to confirm whether to meet randomization criteria. During the treatment period,
      subjects are randomized (1 and 1 ratio) to FFNS 110ug or matching vehicle placebo nasal spray
      to self administer intranasal treatment once daily for 2 weeks. Subjects will rate their
      nasal symptom scores and also document their study drug administration and compliance, any
      medication conditions experienced, and any concomitant medications taken in their dairy
      cards. Subjects also assess the severity of overall interference in activities of diary
      living(ADL) at baseline and the end of study treatment in their questionnaire. At baseline
      and the end of study treatment, investigators rate nasal findings scores by rhinoscopy, and
      record them in patient notes. A follow up telephone contact will be made 3 to 5 days after
      completion of study treatment/early withdrawal to assess for any post treatment adverse
      effects. The primary endpoint is the change from baseline of reflective total nasal symptom
      score(rTNSS) during treatment period, and the secondary endpoints include at completion of
      study treatment, mean change from baseline in nasal finding scores by rhinoscopy, and the
      severity of overall inference in activities of daily living. The safety measures include
      ECGs, vital exams, physical exams, and AE reports. In addition, reflective total ocular
      symptom score(rTOSS) will be measured as an explorative endpoint, only in the specific AR
      patients with severe ocular symptoms.
    

Intervention name(s): fluticasone furoate nasal spray; placebo
Intervention type(s): Drug; Drug
Intervention description(s): fluticasone furoate nasal spray 110ug, once daily; placebo
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: safety; efficacy; placebo; allergic rhinitis; fluticasone furoate