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

NCT ID: NCT01231464

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 365 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-07-31

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.

Conditions

Rhinitis, Allergic, Perennial; Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

placebo

vehicle placebo nasal spray

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

FFNS

fluticasone furoate nasal spray

Group Type: EXPERIMENTAL

fluticasone furoate nasal spray

Intervention Type: DRUG

fluticasone furoate nasal spray 110ug, once daily

Interventions

fluticasone furoate nasal spray

fluticasone furoate nasal spray 110ug, once daily

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Nanjing, Jiangsu, China

GSK Investigational Site

Chengdu, Sichuan, China

GSK Investigational Site

Hangzhou, Zhejiang, China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Wuhan, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 21888757 (View on PubMed)

Other Identifiers

113342

Identifier Type: -

Identifier Source: org_study_id