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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01231464
First received: October 28, 2010
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Rhinitis, Allergic, Perennial
Allergic Rhinitis (Disorder)
Drug: fluticasone furoate nasal spray
Drug: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS) [ Time Frame: Baseline through entire treatment period (Day 1 through Day 14) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy [ Time Frame: Baseline through end of study (Day 1 through Day 15/Early Withdrawal) ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline through end of study (Day 1 through Day 15/Early Withdrawal) ] [ Designated as safety issue: No ]
    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.


Enrollment: 365
Study Start Date: September 2009
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
vehicle placebo nasal spray
Drug: placebo
placebo
Experimental: FFNS
fluticasone furoate nasal spray
Drug: fluticasone furoate nasal spray
fluticasone furoate nasal spray 110ug, once daily

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

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231464

Locations
China, Jiangsu
GSK Investigational Site
Nanjing, Jiangsu, China, 210029
China, Sichuan
GSK Investigational Site
Chengdu, Sichuan, China, 610041
China, Zhejiang
GSK Investigational Site
Hangzhou, Zhejiang, China, 310003
China
GSK Investigational Site
Beijing, China, 100730
GSK Investigational Site
Shanghai, China, 200001
GSK Investigational Site
Shanghai, China, 200031
GSK Investigational Site
Wuhan, China, 430022
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01231464     History of Changes
Other Study ID Numbers: 113342
Study First Received: October 28, 2010
Results First Received: January 22, 2011
Last Updated: March 24, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
safety
efficacy
placebo
allergic rhinitis
fluticasone furoate

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 16, 2014