Rhinitis, Allergic, Perennial Clinical Trial
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)
Verified date | April 2012 |
Source | Teva Pharmaceutical Industries |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 474 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Teva Clinical Study Site | Austin | Texas |
United States | Teva Clinical Study Site | Bangor | Maine |
United States | Teva Clinical Study Site | Bellevue | Washington |
United States | Teva Clinical Study Site | Bethesda | Maryland |
United States | Teva Clinical Study Site | Blue Bell | Pennsylvania |
United States | Teva Clinical Study Site | Brick | New Jersey |
United States | Teva Clinical Study Site | Canton | Ohio |
United States | Teva Clinical Study Site | Charleston | South Carolina |
United States | Teva Clinical Study Site | Dallas | Texas |
United States | Teva Clinical Study Site | Dallas | Texas |
United States | Teva Clinical Study Site | Ft. Worth | Texas |
United States | Teva Clinical Study Site | Indianapolis | Indiana |
United States | Teva Clinical Study Site | Katy | Texas |
United States | Teva Clinical Study Site | Lilburn | Georgia |
United States | Teva Clinical Study Site | Los Angeles | California |
United States | Teva Clinical Study Site | Medford | Oregon |
United States | Teva Clinical Study Site | Miami | Florida |
United States | Teva Clinical Study Site | Mission Viejo | California |
United States | Teva Clinical Study Site | New Braunfels | Texas |
United States | Teva Clinical Study Site | Newport News | Virginia |
United States | Teva Clinical Study Site | Portland | Oregon |
United States | Teva Clinical Study Site | Providence | Rhode Island |
United States | Teva Clinical Study Site | Raleigh | North Carolina |
United States | Teva Clinical Study Site | Richmond | Virginia |
United States | Teva Clinical Study Site | Rolla | Missouri |
United States | Teva Clinical Study Site | San Antonio | Texas |
United States | Teva Clinical Study Site | San Antonio | Texas |
United States | Teva Clinical Study Site | San Diego | California |
United States | Teva Clinical Study Site | San Jose | California |
United States | Teva Clinical Study Site | Spartanburg | South Carolina |
United States | Teva Clinical Study Site | St. Louis | Missouri |
United States | Teva Clinical Study Site | Tallahassee | Florida |
United States | Teva Clinical Study Site | Upland | Pennsylvania |
United States | Teva Clinical Study Site | Waco | Texas |
United States | Teva Clinical Study Site | Winston Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Teva Branded Pharmaceutical Products, R&D Inc. |
United States,
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
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
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 (Sup
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period) | No |
Secondary | 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. |
Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period) | No |
Secondary | 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. | Baseline and Week 6 | No |
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