Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Long-term Efficacy and Safety of BDP HFA Nasal Aerosol (320 mcg, Once Daily) in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)
1 other identifier
interventional
529
1 country
34
Brief Summary
Subjects with perennial allergic rhinitis will be randomized to 320 mcg of beclomethasone dipropionate (BDP) using a hydrofluoroalkane (HFA) propellant or placebo as a nasal aerosol. The subjects will be followed for safety and efficacy for a period of 30 or 52 weeks. BDP HFA is a steroid which is currently FDA approved for the treatment of asthma. BDP-HFA should be safe and effective as a "dry" nasal aerosol which may be preferred by some patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2009
Shorter than P25 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2009
CompletedFirst Posted
Study publicly available on registry
October 2, 2009
CompletedStudy Start
First participant enrolled
October 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2011
CompletedResults Posted
Study results publicly available
May 23, 2012
CompletedDecember 3, 2021
December 1, 2021
1.3 years
September 30, 2009
April 23, 2012
December 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.
Baseline (Days -6 to 0), Day 1 to Week 30
Secondary Outcomes (5)
Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks
Baseline (Days -6 to 0), Day 1 to Week 30
Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks
Baseline (Days -6 to 0), Day 1 to Week 52
Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks
Baseline (Days -6 to 0), Day 1 to Week 52
Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline
Day 0 (Baseline) and Week 30
Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline
Day 0 (Baseline) and Week 52
Study Arms (2)
BDP HFA 320 µg/day
EXPERIMENTALDuring the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning.
Placebo
PLACEBO COMPARATORDuring the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Interventions
Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 30-weeks (or 52-weeks, depending upon investigator site).
Placebo nasal aerosol administered daily for 30-weeks (or 52-weeks, depending upon investigator site).
Eligibility Criteria
You may qualify if:
- Male or female subjects, 12 years of age or 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 subject at increased risk during the study
- A history of PAR to a relevant perennial allergen for a minimum of two years immediately preceding the study Screening Visit (SV). The PAR 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 require treatment throughout the entire study
- A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the diluent control wheal for the skin prick test. Documentation of a positive result 12 months prior to Screening Visit (SV) is acceptable
- Other criteria apply
You may not qualify if:
- History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, including nasal piercing, or surgery and atrophic rhinitis or rhinitis medicamentosa (all within the last 60 days prior to Screening Visit \[SV\])
- 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 a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis, or influenza within the 14 days preceding the Screening Visit (SV) or development of a respiratory infection during the Run-In Period
- Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists and any controller drugs (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable.
- Other criteria apply
- Randomization Criteria
- Subject continues to be in general good health, meeting the selection criteria
- Subject has a minimum subject-reported reflective TNSS of an average of 5 (out of a possible 12) on the last 7 days during the Run-In Period
- The subject-reported scores for rhinorrhea or nasal congestion must be an average of 2 or greater during the last 7 days of the Run-In Period
- Each subject must have adequately completed the electronic AR Assessment Diary (failure is defined as missing the diary entry on more than 2 calendar days during the last 7 days of the Run-In Period)
- Other criteria apply
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Teva Clinical Sudy Site
Oxford, Alabama, 36203, United States
Teva Clinical Study Site
Encinitas, California, 92024, United States
Teva Clinical Study Site
Huntington Beach, California, 92647, United States
Teva Clinical Study Site
San Diego, California, 92120, United States
Teva Clinical Study Site
Stockton, California, 95207, United States
Teva Clinical Study Site
Colorado Springs, Colorado, 80907, United States
Teva Clinical Study Site
Atlanta, Georgia, 30342, United States
Teva Clinical Study Site
Stockbridge, Georgia, 30281, United States
Teva Clinical Study Site
Normal, Illinois, 61761, United States
Teva Clinical Study Site
Lenexa, Kansas, 66215, United States
Teva Clinical Study Site
Overland Park, Kansas, 66210, United States
Teva Clinical Study Site
Metairie, Louisiana, 70006, United States
Teva Clinical Study Site
Wheaton, Maryland, 20902, United States
Teva Clinical Study Site
Ypsilanti, Michigan, 48197, United States
Teva Clinical Study Site
Minneapolis, Minnesota, 55402, United States
Teva Clinical Study Site
Plymouth, Minnesota, 55441, United States
Teva Clinical Study Site
Bozeman, Montana, 59718, United States
Teva Clinical Study Site
North Syracuse, New York, 13212, United States
Teva Clinical Study Site
Rochester, New York, 14618, United States
Teva Clinical Study Site
Rockville Centre, New York, 11570, United States
Teva Clinical Study Site
High Point, North Carolina, 27262, United States
Teva Clinical Study Site
Cincinnati, Ohio, 45231, United States
Teva Clinical Study Site
Sylvania, Ohio, 43560, United States
Teva Clinical Study Site
Eugene, Oregon, 97401, United States
Teva Clinical Study Site
Bethlehem, Pennsylvania, 18020, United States
Teva Clinical Study Site
Collegeville, Pennsylvania, 19426, United States
Teva Clinical Study Site
Dallas, Texas, 75231, United States
Teva Clinical Study Site
El Paso, Texas, 79903, United States
Teva Clinical Study Site
Houston, Texas, 77054, United States
Teva Clinical Study Site
Kerrville, Texas, 78028, United States
Teva Clinical Study Site
San Antonio, Texas, 78229, United States
Teva Clinical Study Site
Vancouver, Washington, 98664, United States
Teva Clinical Study Site
Greenfield, Wisconsin, 53228, United States
Teva Clinical Study Site
West Allis, Wisconsin, 53227, United States
Related Publications (5)
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.
PMID: 22737708RESULTMeltzer 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 2011 (Supplement); 107(11):A118 - Poster presentation.
RESULTCarr 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 once-daily treatment with beclomethasone dipropionate hydrofluoroalkane nasal aerosol. J Allergy Clin Immunol 2012 (Supplement); 129:AB188 - Poster presentation
RESULTGross GN, Settipane RA, Ford LB, Kelley L, Dunbar SA, Tantry SK, Dorinsky PM . Patient Satisfaction and Ease-of-Use of BDP HFA Nasal Aerosol Device in Subjects With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol 2011 (Supplement); 107(11):A119 - Poster presentation
RESULTWeinstein SF, Andrews CP, Shah SR, Chylack LT Jr, Tankelevich A, Ding Y, Tantry SK. Long-term efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol. Allergy Asthma Proc. 2014 Jul-Aug;35(4):323-31. doi: 10.2500/aap.2014.35.3767.
PMID: 24992552DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products, R&D Inc.
Study Officials
- STUDY DIRECTOR
Study Director
Teva Branded
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2009
First Posted
October 2, 2009
Study Start
October 31, 2009
Primary Completion
February 28, 2011
Study Completion
February 28, 2011
Last Updated
December 3, 2021
Results First Posted
May 23, 2012
Record last verified: 2021-12