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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BDP HFA 320 µg/day | Experimental | During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. |
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| Placebo | Placebo Comparator | During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol | Drug | Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudeesh Tantry, Ph.D. | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Clinical Study Site | Los Angeles | California | 90025 | United States | ||
| Teva Clinical Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| Result | 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. | ||
| Result | 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 | ||
| 24169062 |
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During the 7 to 21 day Run-in Period, participants self-administered a single-blind placebo nasal aerosol once daily in the morning and assessed and recorded their twice daily allergic rhinitis symptoms to determine eligibility for randomization.
A total of 675 patients were screened and 574 patients were enrolled in the study and participated in the Run-in Period. Of the 574 enrolled patients, 474 were randomized to study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | BDP HFA 320 µg/Day | During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo Nasal Aerosol | Drug | HFA Vehicle Aerosol |
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| Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period) |
| 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 |
| Mission Viejo |
| California |
| 92691 |
| United States |
| Teva Clinical Study Site | San Diego | California | 92123 | United States |
| Teva Clinical Study Site | San Jose | California | 95117 | United States |
| Teva Clinical Study Site | Miami | Florida | 33173 | United States |
| Teva Clinical Study Site | Tallahassee | Florida | 32308 | United States |
| Teva Clinical Study Site | Lilburn | Georgia | 30047 | United States |
| Teva Clinical Study Site | Indianapolis | Indiana | 46208 | United States |
| Teva Clinical Study Site | Bangor | Maine | 04401 | United States |
| Teva Clinical Study Site | Bethesda | Maryland | 20814 | United States |
| Teva Clinical Study Site | Rolla | Missouri | 65401 | United States |
| Teva Clinical Study Site | St Louis | Missouri | 63141 | United States |
| Teva Clinical Study Site | Brick | New Jersey | 08724 | United States |
| Teva Clinical Study Site | Raleigh | North Carolina | 27607 | United States |
| Teva Clinical Study Site | Winston-Salem | North Carolina | 27103 | United States |
| Teva Clinical Study Site | Canton | Ohio | 44718 | United States |
| Teva Clinical Study Site | Medford | Oregon | 97504 | United States |
| Teva Clinical Study Site | Portland | Oregon | 97213 | United States |
| Teva Clinical Study Site | Blue Bell | Pennsylvania | 19422 | United States |
| Teva Clinical Study Site | Upland | Pennsylvania | 19013 | United States |
| Teva Clinical Study Site | Providence | Rhode Island | 02906 | United States |
| Teva Clinical Study Site | Charleston | South Carolina | 29407 | United States |
| Teva Clinical Study Site | Spartanburg | South Carolina | 29303 | United States |
| Teva Clinical Study Site | Austin | Texas | 78731 | United States |
| Teva Clinical Study Site | Dallas | Texas | 75230 | United States |
| Teva Clinical Study Site | Dallas | Texas | 75231 | United States |
| Teva Clinical Study Site | Fort Worth | Texas | 76132 | United States |
| Teva Clinical Study Site | Katy | Texas | 77450 | United States |
| Teva Clinical Study Site | New Braunfels | Texas | 78130 | United States |
| Teva Clinical Study Site | San Antonio | Texas | 78229 | United States |
| Teva Clinical Study Site | San Antonio | Texas | 78829 | United States |
| Teva Clinical Study Site | Waco | Texas | 76712 | United States |
| Teva Clinical Study Site | Newport News | Virginia | 23606 | United States |
| Teva Clinical Study Site | Richmond | Virginia | 23233 | United States |
| Teva Clinical Study Site | Bellevue | Washington | 68123 | United States |
| 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. |
| 23026182 | Derived | 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. |
| 22737708 | Derived | 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. |
During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily. |
| Intent to Treat Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BDP HFA 320 µg/Day | During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. |
| BG001 | Placebo | During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Demographic data are provided for the Intent to Treat population. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | A participant may select more than one race type. | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Intent-to-Treat (ITT) Population: The ITT population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period) |
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| 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. | Intent to treat population. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period) |
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| 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. | The RQLQ population included adults (18 years and older) with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 6 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BDP HFA 320 µg/Day | During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. | 1 | 236 | 14 | 236 | ||
| EG001 | Placebo | During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily. | 0 | 238 | 12 | 238 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products, R&D Inc. | 215-591-3000 | ustevatrials@tevapharm.com |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Black or African American |
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| American Indian or Alaskan Native |
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| Other |
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| Not Hispanic or Latino |
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