Clinical trial NCT01231464: 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
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Allergic Rhinitis
Keywords: safety
efficacy
placebo
allergic rhinitis
fluticasone furoate
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-11-01
Enrollment: 365
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS)
timeFrame: Baseline through entire treatment period (Day 1 through Day 14)
Secondary outcomes:
measure: Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy
timeFrame: Baseline through end of study (Day 1 through Day 15/Early Withdrawal)
measure: Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Severity of Overall Interference in Activities of Daily Living
timeFrame: Baseline through end of study (Day 1 through Day 15/Early Withdrawal)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Chengdu
country: China
facility: GSK Investigational Site
state: Sichuan
city: Hangzhou
country: China
facility: GSK Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Wuhan
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Han D, Liu S, Zhang Y, Wang J, Wang D, Kong W, Wang S, Cheng L, Zhang L; Chinese Allergic Rhinitis Collaborative Research Group. Efficacy and safety of fluticasone furoate nasal spray in Chinese adult and adolescent subjects with intermittent or persistent allergic rhinitis. Allergy Asthma Proc. 2011 Nov-Dec;32(6):472-81. doi: 10.2500/aap.2011.32.3474. Epub 2011 Aug 31.