Clinical Trial: Study Of Adults And Adolescents With Vasomotor Rhinitis

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

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg f

Brief Summary: The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Mean change from baseline over the entire treatment period in daily reflective total nasal symptom score (rTNSS) [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]

The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).


Original Primary Outcome: Mean change from baseline in daily, reflective total nasal symptom scores.

Current Secondary Outcome:

  • Mean change from baseline over the entire treatment period in morning (AM), pre-dose, instantaneous total nasal symptom scores (iTNSS) [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from baseline was calculated as endpoint value minus the baseline value. Baseline visit was 4 days prior to randomization (Day 1).
  • Number of participants with overall evaluation of response to therapy [ Time Frame: Up to 4 weeks ]
    The Overall Evaluation of Response to Therapy was based on a 7-point categorical scale where the participants rated their perception of the change or lack of change in their VMR (Vasomotor rhinitis) symptoms at the end of the study. The 7 categories were: significantly improved, moderately improved, mildly improved, no change, mildly worse, moderately worse, and significantly worse.
  • Mean change from baseline over the entire treatment period in AM pre-dose rTNSS [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). Change from Baseline was calculated as post randomization value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
  • Mean change from baseline over the entire treatment period in evening (PM) rTNSS [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the PM (PM rTNSS). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
  • Mean percent change from baseline over the entire treatment period in daily rTNSS [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
  • Mean percent change from baseline over the entire treatment period in AM, pre-dose iTNSS [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
  • Mean change from baseline over the entire treatment period in individual daily, reflective nasal symptom scores for rhinorrhea, nasal congestion and post-nasal drip [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    The daily reflective nasal symptom scores was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
  • Mean change from baseline over the entire treatment period in individual AM, pre-dose, instantaneous, nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    The AM, pre-dose, instantaneous nasal symptom score is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
  • Mean change from baseline over the entire treatment period in individual AM, reflective nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on

    Original Secondary Outcome:

    • Mean change from baseline in AM, pre-dose, instantaneous total nasal symptom scores.
    • Overall evaluation of response to therapy.


    Information By: GlaxoSmithKline

    Dates:
    Date Received: June 30, 2005
    Date Started: July 11, 2005
    Date Completion:
    Last Updated: April 20, 2017
    Last Verified: April 2017