Clinical trial NCT01024608: Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate Hydrofluoroalkane (BDP HFA) Nasal Aerosol in Subjects 12 Years of Age and Older With SAR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Hay Fever
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-03
Enrollment: 340
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
timeFrame: Baseline (Days -3 to 0), and Days 1-15
Secondary outcomes:
measure: Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
timeFrame: Baseline (Days -3 to 0), and Days 1-15
measure: Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline
timeFrame: Day 0 (Baseline), Day 15
measure: Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period
timeFrame: Baseline (Days -3 to 0), and Days 1-15
Other outcomes:
Locations:
city: Austin
country: United States
facility: Teva Clinical Trial Site
state: Texas
city: New Braunfels
country: United States
facility: Teva Clinical Trial Site
state: Texas
city: San Antonio
country: United States
facility: Teva Clinical Trial Site
state: Texas
city: Waco
country: United States
facility: Teva Clinical Trial Site
state: Texas
Study officials:
affiliation: Teva Branded
name: Sudeesh Tantry, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Van Bavel J, Hampel, FC, Ratner PH, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2011). BDP HFA Nasal Aerosol Effectively Improves Nasal Symptom Relief and Health-Related Quality of Life (QOL) in Subjects with Seasonal Allergic Rhinitis (SAR). J Allergy Clin Immunol. 127(2):201.
citation: 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.
citation: 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.