The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
474
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
HFA Vehicle Aerosol
Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \& PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Time frame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-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.
Time frame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
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.
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Teva Clinical Study Site
Los Angeles, California, United States
Teva Clinical Study Site
Mission Viejo, California, United States
Teva Clinical Study Site
San Diego, California, United States
Teva Clinical Study Site
San Jose, California, United States
Teva Clinical Study Site
Miami, Florida, United States
Teva Clinical Study Site
Tallahassee, Florida, United States
Teva Clinical Study Site
Lilburn, Georgia, United States
Teva Clinical Study Site
Indianapolis, Indiana, United States
Teva Clinical Study Site
Bangor, Maine, United States
Teva Clinical Study Site
Bethesda, Maryland, United States
...and 25 more locations
Time frame: Baseline and Week 6