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

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

Sponsors

Lead Sponsor: GlaxoSmithKline

Source GlaxoSmithKline
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.

Overall Status Completed
Start Date September 2009
Completion Date July 2010
Primary Completion Date May 2010
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS) Baseline through entire treatment period (Day 1 through Day 14)
Secondary Outcome
Measure Time Frame
Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy Baseline through end of study (Day 1 through Day 15/Early Withdrawal)
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 Baseline through end of study (Day 1 through Day 15/Early Withdrawal)
Enrollment 365
Condition
Intervention

Intervention Type: Drug

Intervention Name: fluticasone furoate nasal spray

Description: fluticasone furoate nasal spray 110ug, once daily

Arm Group Label: FFNS

Intervention Type: Drug

Intervention Name: placebo

Description: placebo

Arm Group Label: placebo

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

Gender: All

Minimum Age: 12 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials Study Director GlaxoSmithKline
Location
Facility:
GSK Investigational Site | Nanjing, Jiangsu, 210029, China
GSK Investigational Site | Chengdu, Sichuan, 610041, China
GSK Investigational Site | Hangzhou, Zhejiang, 310003, China
GSK Investigational Site | Beijing, 100730, China
GSK Investigational Site | Shanghai, 200001, China
GSK Investigational Site | Shanghai, 200031, China
GSK Investigational Site | Wuhan, 430022, China
Location Countries

China

Verification Date

June 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: placebo

Type: Placebo Comparator

Description: vehicle placebo nasal spray

Label: FFNS

Type: Experimental

Description: fluticasone furoate nasal spray

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov