Clinical Trial: Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study FFR116364, a Double-blind, Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

Brief Summary: Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in Japanese paediatric subjects ages 6 to < 15 years with perennial allergic rhinitis will be evaluated compared with placebo.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period [ Time Frame: Baseline through the entire treatment period (2 weeks) ]

Original Primary Outcome: Mean change from baseline in 3TNSS (total nasal symptom score) [ Time Frame: the entire treatment period (2 weeks) ]

Current Secondary Outcome:

• Mean Change From Baseline in 3TNSS at Week 1 and Week 2 [ Time Frame: Baseline; Week 1 and Week 2 ]
  The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For Week 1 and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score at Week 1 and Week 2 minus the score at Baseline.
• Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 [ Time Frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 ]
  The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.
• Mean Change From Baseline in 3TNSS at the Indicated Days [ Time Frame: Baseline; Days 1 through 14 ]
  The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). Change from Baseline was calculated as the mean score at the indicated day minus the score at Baseline.
• Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 [ Time Frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 ]
  The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
• Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 [ Time Frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 ]
  The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 4TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.
• Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1
  
  

  Original Secondary Outcome:

  • Mean change from baseline in 3TNSS [ Time Frame: Week 1 and Week 2 ]
    A subject's parent/guardian who signed ICF or a subject will score nasal symptoms everyday during the screening period and treatment period.
  • Mean change from baseline in 4TNSS [ Time Frame: the entire treatment period (2 weeks), Week 1 and Week 2 ]
    The 4 total nasal symptom score (4TNSS) is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion and nasal itching where each symptom is scored on a scale of 0 to 3 (The maximum sum for a 4TNSS is 12). A subject's parent/guardian who signed ICF or a subject will score nasal symptoms everyday during the screening period and treatment period.
  • Mean change from baseline in each individual nasal symptom score; sneezing, rhinorrhea, nasal congestion and nasal itching [ Time Frame: the entire treatment period (2 weeks), Week 1 and Week 2 ]
    A subject's parent/guardian who signed ICF or a subject will score nasal symptoms everyday during the screening period and treatment period.
  • Mean change from baseline in TOSS (total ocular symptom score) [ Time Frame: the entire treatment period (2 weeks), Week 1 and Week 2 ]
    The total ocular symptom score (TOSS) is the sum of the 3 individual symptom scores for eye itching, tearing and redness where each symptom is scored on a scale of 0 to 3 (The maximum sum for a TOSS is 9). A subject's parent/guardian who signed ICF or a subject will score ocular symptoms everyday during the screening period and treatment period.
  • Mean change from baseline in score of troubles with daily life [ Time Frame: the entire treatment period (2 weeks), Week 1 and Week 2 ]
    A subject's parent/guardian who signed ICF or a subject will score the score of troubles with daily life everyday during the screening period and treatment period.
  • Change from baseline in rhinoscopy findings [ Time Frame: 2 weeks ]
    Change from baseline in rhinoscopy findings (swelling of inferior turbinate mucosa, colour of inferior turbinate mucosa, quantity of nasal discharge and quality of nasal discharge).
  • Overall evaluation of response to therapy [ Time Frame: 2 weeks ]
    Subject's overall response to therapy (improvement in the symptoms of allergic rhinitis) compared with Visit 2
  
  
  Information By: GlaxoSmithKline
  

  Dates:
  Date Received: June 26, 2012
  Date Started: June 2012
  Date Completion:
  Last Updated: November 20, 2016
  Last Verified: November 2016