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The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BDP HFA 80 mcg/day | Experimental | Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. |
|
| BDP HFA 160 mcg/day | Experimental | Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. |
|
| Placebo nasal aerosol once daily | Placebo Comparator | Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDP HFA | Drug | BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment | Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization. | Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment | Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
Baseline was defined as the average AM and PM subject-reported iTNSS over the 4 days prior to randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Clinical Study Site | Oxford | Alabama | 36203 | United States | ||
| Teva Clinical Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24125150 | Derived | Storms WW, Segall N, Mansfield LE, Amar NJ, Kelley L, Ding Y, Tantry SK. Efficacy and safety of beclomethasone dipropionate nasal aerosol in pediatric patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2013 Nov;111(5):408-414.e1. doi: 10.1016/j.anai.2013.07.033. Epub 2013 Aug 28. |
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A total of 1026 subjects were screened and 906 were enrolled and participated in the Run-in Period. Of the 906 enrolled subjects, 715 were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | BDP HFA 80 mcg/Day | Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. |
| FG001 | BDP HFA 160 mcg/Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo nasal aerosol | Drug | Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period. |
|
| Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15 |
| Bell |
| California |
| 90201 |
| United States |
| Teva Clinical Study Site | Costa Mesa | California | 92626 | United States |
| Teva Clinical Study Site | Mission Viejo | California | 92691 | United States |
| Teva Clinical Study Site | Orange | California | 92868 | United States |
| Teva Clinical Study Site | Paramount | California | 90723 | United States |
| Teva Clinical Study Site | San Diego | California | 92120 | United States |
| Teva Clinical Study Site | San Diego | California | 92123 | United States |
| Teva Clinical Study Site | Stockton | California | 95207 | United States |
| Teva Clinical Study Site | Centennial | Colorado | 80112 | United States |
| Teva Clinical Study Site | Colorado Springs | Colorado | 80907 | United States |
| Teva Clinical Study Site | Gainesville | Georgia | 30501 | United States |
| Teva Clinical Study Site | Lawrenceville | Georgia | 30046 | United States |
| Teva Clinical Study Site | Savannah | Georgia | 31406 | United States |
| Teva Clinical Study Site | Stockbridge | Georgia | 30281 | United States |
| Teva Clinical Study Site | Indianapolis | Indiana | 43208 | United States |
| Teva Clinical Study Site | Bethesda | Maryland | 20814 | United States |
| Teva Clinical Study Site | Minneapolis | Minnesota | 55402 | United States |
| Teva Clinical Study Site | Plymouth | Minnesota | 55441 | United States |
| Teva Clinical Study Site | Columbia | Missouri | 65203 | United States |
| Teva Clinical Study Site | Rolla | Missouri | 65401 | United States |
| Teva Clinical Study Site | Warrensburg | Missouri | 64093 | United States |
| Teva Clinical Study Site | Bozeman | Montana | 597158 | United States |
| Teva Clinical Study Site | Brick | New Jersey | 08724 | United States |
| Teva Clinical Study Site | High Point | North Carolina | 27262 | United States |
| Teva Clinical Study Site | Oklahoma City | Oklahoma | 73102 | 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 | Collegeville | Pennsylvania | 19426 | United States |
| Teva Clinical Study Site | Philadelphia | Pennsylvania | 19115 | United States |
| Teva Clinical Study Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Teva Clinical Study Site | Charleston | South Carolina | 20460 | United States |
| Teva Clinical Study Site | Orangeburg | South Carolina | 29119 | 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 | 75246 | United States |
| Teva Clinical Study Site | El Paso | Texas | 79903 | United States |
| Teva Clinical Study Site | Fort Worth | Texas | 76132 | United States |
| Teva Clinical Study Site | Houston | Texas | 77054 | United States |
| Teva Clinical Study Site | Kerrville | Texas | 78028 | 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 | Waco | Texas | 76712 | United States |
| Teva Clinical Study Site | Burke | Virginia | 22015 | United States |
| Teva Clinical Study Site | Richmond | Virginia | 23233 | United States |
Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
| FG002 | Placebo Nasal Aerosol Once Daily | Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days. |
| Safety Population |
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| ITT Population |
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| COMPLETED |
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| NOT COMPLETED |
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Safety population: the safety population included all randomized participants who received at least one dose of randomized study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | BDP HFA 80 mcg/Day | Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. |
| BG001 | BDP HFA 160 mcg/Day | Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. |
| BG002 | Placebo Nasal Aerosol Once Daily | Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment | Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
Baseline was defined as the average AM and PM subject-reported iTNSS over the 4 days prior to randomization. | The intent to treat (ITT) population included all randomized participants who received at least one dose of randomized study medication and had at least one post-baseline assessment. Two enrolled participants were excluded. One was randomized in error and did not receive test medication. The other provided no post-baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15 |
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| Primary | Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment | Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization. | The intent to treat (ITT) population included all randomized participants who received at least one dose of randomized study medication and had at least one post-baseline assessment. Two enrolled participants were excluded. One was randomized in error and did not receive test medication. The other provided no post-baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15 |
|
Day 1 to 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 80 mcg/Day | Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. | 0 | 239 | 0 | 239 | ||
| EG001 | BDP HFA 160 mcg/Day | Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. | 0 | 241 | 0 | 241 | ||
| EG002 | Placebo Nasal Aerosol Once Daily | Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days. | 0 | 234 | 0 | 234 |
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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 |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C048053 | alpha-ketoisovalerate dehydrogenase phosphatase |
| D001507 | Beclomethasone |
| C094049 | apaflurane |
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Male |
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| Black or African American |
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| Asian |
|
| Other |
|
| Not Hispanic or Latino |
|
| mixed-model for repeated measures (MMRM) |
The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction. |
| <0.001 |
a priori statistical significance is <0.05. |
| LSM treatment difference from placebo |
| -0.73 |
| 2-Sided |
| 95 |
| -1.1 |
| -0.4 |
| No |
| Superiority or Other |
| OG001 | BDP HFA 160 mcg/Day | Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. |
| OG002 | Placebo Nasal Aerosol Once Daily | Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days. |
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