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

Rhinitis, Allergic, Perennial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231464
• Other study ID #: 113342
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2010
• Last updated: March 24, 2011
• Start date: September 2009
• Est. completion date: July 2010

Study information

• Verified date: March 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis (Disorder)
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• fluticasone furoate nasal spray
fluticasone furoate nasal spray 110ug, once daily
• placebo
placebo

Locations

Country	Name	City	State
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Chengdu	Sichuan
China	GSK Investigational Site	Hangzhou	Zhejiang
China	GSK Investigational Site	Nanjing	Jiangsu
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy	The nasal finding score by rhinoscopy (possible score of 0-12) is the sum of 4 individual investigator assessed scores for swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume, and description of rhinorrhea. The symptoms were assessed using a scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. Mean change from baseline to the end of study in nasal finding score by rhinoscopy was calculated as the nasal finding score by rhinoscopy at Visit 4/Early Withdrawal minus the nasal final finding score by rhinoscopy at Visit 2.	Baseline through end of study (Day 1 through Day 15/Early Withdrawal)	No
Secondary	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	The severity of overall interference in activities of daily living at baseline and the end of study was assessed by the investigator on the scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. The mean change from baseline to the end of study in severity of overall interference in activities of daily living was calculated as the severity of overall interference in activities of daily living at Visit 4/Early Withdrawal minus severity of overall interference in activities of daily living at Visit 2.	Baseline through end of study (Day 1 through Day 15/Early Withdrawal)	No