Clinical trial NCT01134705: Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol (320 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (12 Years of Age and Older)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 474
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 perennial allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Informed Consent
* Documented history of perennial allergic rhinitis
* A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.
* Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12)
* 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 or during the run-in period
* Use of any prohibited concomitant medications

Primary outcomes:
measure: Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period
timeFrame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Secondary outcomes:
measure: Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period
timeFrame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Teva Clinical Study Site
state: California
city: Mission Viejo
country: United States
facility: Teva Clinical Study Site
state: California
city: San Diego
country: United States
facility: Teva Clinical Study Site
state: California
city: San Jose
country: United States
facility: Teva Clinical Study Site
state: California
city: Miami
country: United States
facility: Teva Clinical Study Site
state: Florida
city: Tallahassee
country: United States
facility: Teva Clinical Study Site
state: Florida
city: Lilburn
country: United States
facility: Teva Clinical Study Site
state: Georgia
city: Indianapolis
country: United States
facility: Teva Clinical Study Site
state: Indiana
city: Bangor
country: United States
facility: Teva Clinical Study Site
state: Maine
city: Bethesda
country: United States
facility: Teva Clinical Study Site
state: Maryland
city: Rolla
country: United States
facility: Teva Clinical Study Site
state: Missouri
city: St. Louis
country: United States
facility: Teva Clinical Study Site
state: Missouri
city: Brick
country: United States
facility: Teva Clinical Study Site
state: New Jersey
city: Raleigh
country: United States
facility: Teva Clinical Study Site
state: North Carolina
city: Winston Salem
country: United States
facility: Teva Clinical Study Site
state: North Carolina
city: Canton
country: United States
facility: Teva Clinical Study Site
state: Ohio
city: Medford
country: United States
facility: Teva Clinical Study Site
state: Oregon
city: Portland
country: United States
facility: Teva Clinical Study Site
state: Oregon
city: Blue Bell
country: United States
facility: Teva Clinical Study Site
state: Pennsylvania
city: Upland
country: United States
facility: Teva Clinical Study Site
state: Pennsylvania
city: Providence
country: United States
facility: Teva Clinical Study Site
state: Rhode Island
city: Charleston
country: United States
facility: Teva Clinical Study Site
state: South Carolina
city: Spartanburg
country: United States
facility: Teva Clinical Study Site
state: South Carolina
city: Austin
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Ft. Worth
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Katy
country: United States
facility: Teva Clinical Study Site
state: Texas
city: New Braunfels
country: United States
facility: Teva Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: Teva Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Waco
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Newport News
country: United States
facility: Teva Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: Teva Clinical Study Site
state: Virginia
city: Bellevue
country: United States
facility: Teva Clinical Study Site
state: Washington
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Sudeesh Tantry, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK (2011). BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
citation: Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. . BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol (Supplement); 107(11):A118 - Poster presentation.
citation: Carr W, Meltzer EO, Finn A, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. Effective nasal symptom relief and improvement in health-related quality of life in subjects with perennial allergic rhinitis following 6-week
citation: Meltzer EO, Korenblat PE, Lanier BQ, Kelley L, Tantry SK. Beclomethasone dipropionate nasal aerosol with an integrated dose counter: functionality and performance. Allergy Asthma Proc. 2013 Nov-Dec;34(6):534-41. doi: 10.2500/aap.2013.34.3707.
citation: Nayak AS, Atiee GJ, Dige E, Maloney J, Nolte H. Safety of ragweed sublingual allergy immunotherapy tablets in adults with allergic rhinoconjunctivitis. Allergy Asthma Proc. 2012 Sep-Oct;33(5):404-10. doi: 10.2500/aap.2012.33.3605.
citation: Meltzer EO, Jacobs RL, LaForce CF, Kelley CL, Dunbar SA, Tantry SK. Safety and efficacy of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with perennial allergic rhinitis. Allergy Asthma Proc. 2012 May-Jun;33(3):249-57. doi: 10.2500/aap.2012.33.3571.