Clinical trial NCT00854360: Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR
Official title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Range-Finding Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Adult and Adolescent Patients (12 Years and Older) With Seasonal Allergic Rhinitis (SAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Hayfever
Keywords: Seasonal Allergic Rhinitis
Hayfever
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-03
Enrollment: 487
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: This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.


Eligibility criteria: Key Inclusion Criteria:

* Male or female patients 12 years of age and older, as of the Screening Visit (SV).
* General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
* A history of SAR to relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the investigator's judgment is expected to be exposed to the allergen and require treatment throughout the entire study period.
* A demonstrated sensitivity to relevant tree/grass pollen known to produce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result within 12 months prior to Screening Visit (SV) is acceptable.
* Other criteria apply

Key Exclusion Criteria:

* Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study.
* History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the SV).
* History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
* Use of any prohibited concomitant medications within the prescribed (per protocol) time since the last dosing period prior to the Screening Visit (SV) and/or plans for use during the entire treatment duration.
* Other criteria apply

Primary outcomes:
measure: Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
timeFrame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Secondary outcomes:
measure: Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period
timeFrame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
measure: Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
timeFrame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
timeFrame: Baseline and Week 2
measure: Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period
timeFrame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
measure: Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period
timeFrame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Teva Global Respiratory Research Study Site
state: California
city: San Diego
country: United States
facility: Teva Global Respiratory Research Study Site
state: California
city: San Diego
country: United States
facility: Teva Global Respiratory Research Study Site
state: California
city: Colorado Springs
country: United States
facility: Teva Global Respiratory Research Study Site
state: Colorado
city: Denver
country: United States
facility: Teva Global Respiratory Research Study Site
state: Colorado
city: Gainesville
country: United States
facility: Teva Global Respiratory Research Study Site
state: Georgia
city: Savannah
country: United States
facility: Teva Global Respiratory Research Study Site
state: Georgia
city: Indianapolis
country: United States
facility: Teva Global Respiratory Research Study Site
state: Indiana
city: Overland Park
country: United States
facility: Teva Global Respiratory Research Study Site
state: Kansas
city: Bethesda
country: United States
facility: Teva Global Respiratory Research Study Site
state: Maryland
city: St. Louis
country: United States
facility: Teva Global Respiratory Research Study Site
state: Missouri
city: Brick
country: United States
facility: Teva Global Respiratory Research Study Site
state: New Jersey
city: Raleigh
country: United States
facility: Teva Global Respiratory Research Study Site
state: North Carolina
city: Medford
country: United States
facility: Teva Global Respiratory Research Study Site
state: Oregon
city: Portland
country: United States
facility: Teva Global Respiratory Research Study Site
state: Oregon
city: Blue Bell
country: United States
facility: Teva Global Respiratory Research Study Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Global Respiratory Research Study Site
state: Pennsylvania
city: Upland
country: United States
facility: Teva Global Respiratory Research Study Site
state: Pennsylvania
city: Charleston
country: United States
facility: Teva Global Respiratory Research Study Site
state: South Carolina
city: Austin
country: United States
facility: Teva Global Respiratory Research Study Site
state: Texas
city: Dallas
country: United States
facility: Teva Global Respiratory Research Study Site
state: Texas
city: New Braunfels
country: United States
facility: Teva Global Respiratory Research Study Site
state: Texas
city: San Antonio
country: United States
facility: Teva Global Respiratory Research Study Site
state: Texas
city: Draper
country: United States
facility: Teva Global Respiratory Research Study Site
state: Utah
city: Burke
country: United States
facility: Teva Global Respiratory Research Study Site
state: Virginia
city: Richmond
country: United States
facility: Teva Global Respiratory Research Study Site
state: Virginia
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Sudeesh Tantry, Ph.D.
role: STUDY_CHAIR
References:
citation: Raphael GD, Berger WE, Prenner BM, Finn AF Jr, Kelley L, Tantry SK. Efficacy, safety, and optimal dose selection of beclomethasone dipropionate nasal aerosol for seasonal allergic rhinitis in adolescents and adults. Curr Med Res Opin. 2013 Oct;29(10):1329-40. doi: 10.1185/03007995.2013.821055. Epub 2013 Aug 6.