Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

• Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period [ Time Frame: Baseline (Days -3 to 0), and Days 1-15 ] [ Designated as safety issue: No ]

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

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

  The iTNSS (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 at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline [ Time Frame: Day 0 (Baseline), Day 15 ] [ Designated as safety issue: No ]
  The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of 'emotional' utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement.
• Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period [ Time Frame: Baseline (Days -3 to 0), and Days 1-15 ] [ Designated as safety issue: No ]

  Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:

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

  The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement.

• Average morning and evening subject-reported instantaneous TNSS over the two-week Treatment Period [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
• Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at week 2 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: Two weeks ] [ Designated as safety issue: No ]
• Average morning and evening subject-reported reflective ocular symptom score (the sum of individual non-nasal symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness) over the two-week Treatment Period [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

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 seasonal allergic rhinitis.

• Seasonal Allergic Rhinitis
• Hay Fever

• Drug: Beclomethasone dipropionate
  Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks.
  Other Name: QNASL(TM)
• Drug: Placebo Nasal Aerosol
  Placebo nasal aerosol administered each morning for two weeks.

• Experimental: BDP HFA 320 µg/day
  During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning.
  Intervention: Drug: Beclomethasone dipropionate
• Placebo Comparator: Placebo
  During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
  Intervention: Drug: Placebo Nasal Aerosol

• Van Bavel J, Ratner PH, Amar NJ, Hampel FC, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 μg Once Daily Effectively Improves Ocular Symptoms Associated With Seasonal Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
• Van Bavel J, Dorinsky PM, Melchior A, Dunbar SA, and Tantry SK (2011). Nasal Symptom Relief and Improvement in Health-Related Quality of Life Following Treatment with BDP HFA Nasal Aerosol (320 mcg Once Daily) in Subjects with Seasonal Allergic Rhinitis. Allergy Asthma Proc. 32(4):330.
• Van Bavel J, Amar NJ, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2010).BDP HFA Nasal Aerosol, 320 mcg Once Daily, is Safe and Effective in the Treatment of Nasal Symptoms Associated with Seasonal Allergic Rhinitis (SAR). Ann Allergy Asthma Immunol. 105(5):121.
• van Bavel JH, Ratner PH, Amar NJ, Hampel FC Jr, Melchior A, Dunbar SA, Dorinsky PM, Tantry SK. Efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2012 Sep-Oct;33(5):386-96. doi: 10.2500/aap.2012.33.3593.

Inclusion Criteria:

• Informed Consent
• Male or female subjects 12 years of age or older
• Documented history of season allergic rhinitis to mountain cedar pollen
• General good health
• Other criteria apply

Exclusion Criteria:

• History of physical findings of nasal pathology (within 60 days prior to screening visit)
• Participation in any investigational drug study 30 days preceding screening visit
• History of respiratory infection/disorder with 14 days preceding screening visit
• Use of any prohibited concomitant medications
• Other criteria apply