Rhinitis, Allergic, PerennialPhase 3NCT00988247
Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis
A Phase 3 study testing Beclomethasone dipropionate in people with Rhinitis, Allergic, Perennial, run by Teva Branded Pharmaceutical Products R&D, Inc. at 34 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Beclomethasone dipropionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 529 participants
- Where
- 34 sitesUnited States
- Study dates
- 31 Oct 2009to 28 Feb 2011
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Teva Clinical Study Site
Atlanta, Georgia, 30342
Teva Clinical Study Site
Bethlehem, Pennsylvania, 18020
Teva Clinical Study Site
Bozeman, Montana, 59718
Teva Clinical Study Site
Cincinnati, Ohio, 45231
Teva Clinical Study Site
Collegeville, Pennsylvania, 19426
Teva Clinical Study Site
Colorado Springs, Colorado, 80907
Teva Clinical Study Site
Dallas, Texas, 75231
Teva Clinical Study Site
El Paso, Texas, 79903
Teva Clinical Study Site
Encinitas, California, 92024
Teva Clinical Study Site
Eugene, Oregon, 97401
Teva Clinical Study Site
Greenfield, Wisconsin, 53228
Teva Clinical Study Site
High Point, North Carolina, 27262
Teva Clinical Study Site
Houston, Texas, 77054
Teva Clinical Study Site
Huntington Beach, California, 92647
Teva Clinical Study Site
Kerrville, Texas, 78028
Teva Clinical Study Site
Lenexa, Kansas, 66215
Teva Clinical Study Site
Metairie, Louisiana, 70006
Teva Clinical Study Site
Minneapolis, Minnesota, 55402
Teva Clinical Study Site
Normal, Illinois, 61761
Teva Clinical Study Site
North Syracuse, New York, 13212
Teva Clinical Study Site
Overland Park, Kansas, 66210
Teva Clinical Sudy Site
Oxford, Alabama, 36203
Teva Clinical Study Site
Plymouth, Minnesota, 55441
Teva Clinical Study Site
Rochester, New York, 14618
Teva Clinical Study Site
Rockville Centre, New York, 11570
Teva Clinical Study Site
San Antonio, Texas, 78229
Teva Clinical Study Site
San Diego, California, 92120
Teva Clinical Study Site
Stockbridge, Georgia, 30281
Teva Clinical Study Site
Stockton, California, 95207
Teva Clinical Study Site
Sylvania, Ohio, 43560
Teva Clinical Study Site
Vancouver, Washington, 98664
Teva Clinical Study Site
West Allis, Wisconsin, 53227
Teva Clinical Study Site
Wheaton, Maryland, 20902
Teva Clinical Study Site
Ypsilanti, Michigan, 48197
About this study
Official title: 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)
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.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Beclomethasone dipropionate, Placebo Nasal Aerosol
- Keywords
- Rhinitis, Allergic, Perennial, BDP-HFA, Hay fever, Allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclomethasone dipropionateDrug
Also called QNASL(TM)
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 AerosolDrug
Placebo nasal aerosol administered daily for 30-weeks (or 52-weeks, depending upon investigator site).
| Study group | Role | What they receive |
|---|---|---|
| BDP HFA 320 µg/day | Experimental | During 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. Receives: Drug: Beclomethasone dipropionate |
| Placebo | Placebo comparator | During 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. Receives: Drug: Placebo Nasal Aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (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.
Measured: 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
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.
Measured: 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
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (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.
Measured: 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
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.
Week 30 scores were compared to baseline scores. A negative change score indicates improvement.
Measured: 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
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.
Week 52 scores were compared to baseline scores. A negative change score indicates improvement.
Measured: Day 0 (Baseline) and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study start31 Oct 2009
- Primary completion28 Feb 2011
- Study completion28 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Teva Branded
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988247
- Sponsor's protocol ID
- BDP-AR-303
- Status last verified
- Dec 2021
- First submitted
- 30 Sep 2009
- Last updated
- 3 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22737708Meltzer 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.
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 once-daily treatment with beclomethasone dipropionate hydrofluoroalkane nasal aerosol. J Allergy Clin Immunol 2012 (Supplement); 129:AB188 - Poster presentation
Gross 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
Weinstein 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.
PubMed 24992552