Original Primary Outcome: Average of subject-reported reflective Total Nasal Symptom Score (TNSS) over the six-week Treatment Period [ Time Frame: 6 weeks ]

Current Secondary Outcome:

• Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period [ Time Frame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period) ]

  Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM & PM) using the following scale:

  0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping).

  The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.

• Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: Baseline and Week 6 ]
  The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement.

Original Secondary Outcome:

• Average of subject-reported instantaneous TNSS over the six-week Treatment Period [ Time Frame: 6 weeks ]
• RQLQ at week 6 for subjects with impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit (RV) of 3.0 or greater [ Time Frame: 6 weeks ]

Dates:
Date Received: May 27, 2010
Date Started: May 2010
Date Completion:
Last Updated: April 23, 2012
Last Verified: April 2012