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

NCT01231464 | Completed Phase 3 Results

• 1 other identifier: 113342
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 7

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.

Conditions

Rhinitis, Allergic, Perennial; Allergic Rhinitis

Keywords

safety; efficacy; placebo; allergic rhinitis; fluticasone furoate

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS)

  The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS was performed in the morning (AM rTNSS) and evening (PM rTNSS) and assessed the participant's symptoms over the preceding 12 hours. The daily rTNSS is the average of the AM rTNSS and PM rTNSS assessments. Mean changes from baseline over the entire treatment period were calculated as treatment period rTNSS minus baseline rTNSS.

  Baseline through entire treatment period (Day 1 through Day 14)

Secondary Outcomes (2)

• 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)

Study Arms (2)

placebo

PLACEBO COMPARATOR

vehicle placebo nasal spray

Drug: placebo

FFNS

EXPERIMENTAL

fluticasone furoate nasal spray

Drug: fluticasone furoate nasal spray

Interventions

fluticasone furoate nasal spray DRUG

fluticasone furoate nasal spray 110ug, once daily

FFNS

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects can be enrolled when meeting all criteria as below.
• Chinese adolescent and adult (male or eligible female) outpatients with the age of \>=12 years
• 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)
• Subject must be symptomatic at screening and willing to maintain same environment throughout the study
• Ability to comply with study procedures
• Literate

You may not qualify if:

• Subjects should be excluded when meeting one of criteria as below.
• Having complications of nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis
• Having complications of bacterial/viral infection of upper respiratory tract
• Having significant systemic diseases
• History of hypersensitivity to steroids and ingredients
• Pregnant women or under lactation
• Patients who started, discontinued or changed dose of desensitization therapy within 30 days before visit 1
• Patients planning to travel outside the region
• Patients judged to be inappropriate by investigators
• Patients who participated in another study within 4 months before screening
• Patients who could not withdraw drugs during screening period or secure withdrawal period until the initiation day of administration, e.g.
• allergy medications
• other medications that may affect allergic rhinitis or its symptoms
• any medications that significantly inhibit CYP3A4, including ritonavir and ketoconazole

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Nanjing, Jiangsu, 210029, China

Location

GSK Investigational Site

Chengdu, Sichuan, 610041, China

Location

GSK Investigational Site

Hangzhou, Zhejiang, 310003, China

Location

GSK Investigational Site

Beijing, 100730, China

Location

GSK Investigational Site

Shanghai, 200001, China

Location

GSK Investigational Site

Shanghai, 200031, China

Location

GSK Investigational Site

Wuhan, 430022, China

Location

Related Publications (1)

• 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.

  PMID: 21888757 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 1, 2010
• Study Start: September 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 6, 2017
• Results First Posted: February 4, 2011

Record last verified: 2017-06

Locations

CN (7)