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This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albuterol-HFA-BAI | Experimental | ProAir(TM) HFA, Breath Actuated Inhalation Aerosol |
|
| Placebo-HFA-BAI | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol | Drug | Albuterol 90mcg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22 | The baseline FEV1 was defined as the average of the two predose measurements ( at -0.5 and 0.0 hour) on the test day (Day 22). The mean was obtained from the analysis of covariance (ANCOVA) adjusted for baseline FEV1 and the pooled investigational center. | Baseline (Predose at Day 22), 2 hours postdose at Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22 | Baseline-adjusted PPFEV1 AUEC0-6 on Study Day 22 was determined using both the Day 1 and Day 22 baselines. | Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, M.D. | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock Allergy and Asthma | Little Rock | Arkansas | 72205-4565 | United States | ||
| Allergy & Asthma Specialist Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Albuterol-HFA-BAI | Participants received albuterol |
| FG001 | Placebo-HFA-BAI | Participants received placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Placebo |
|
| Huntington Beach |
| California |
| 92647 |
| United States |
| Allergy & Asthma Associates of Santa Clara Valley Research Center | San Jose | California | 95117 | United States |
| William Storms Medical Research | Colorado Springs | Colorado | 80907 | United States |
| Colorado Allergy and Asthma Centers, PC | Denver | Colorado | 80230 | United States |
| Colorado Allergy and Asthma Centers, PC | Englewood | Colorado | 80112 | United States |
| Colorado Allergy and Asthma Centers, PC | Lakewood | Colorado | 80401 | United States |
| Southern Allergy & Asthma, PC | Savannah | Georgia | 31405 | United States |
| Sneeze, Wheeze & Itch Associates, Inc. | Normal | Illinois | 61761 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| The Asthma & Allergy Center, PC | Papillion | Nebraska | 68046 | United States |
| Allergy and Respiratory Center | Canton | Ohio | 44718 | United States |
| Allergy, Asthma & Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Pediatric Pulmonary Associates of North Texas | Dallas | Texas | 75230 | United States |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Albuterol-HFA-BAI | Participants received albuterol |
| BG001 | Placebo-HFA-BAI | Participants received placebo |
| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Forced Expiratory Volume in 1 Second (FEV1) | The baseline FEV1 was defined as the average of the 2 test-day (Day 22) predose (-0.5 and 0.0 hour prior to dosing) baseline FEV1 values. | Mean | Standard Deviation | liters |
|
| 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 | Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22 | The baseline FEV1 was defined as the average of the two predose measurements ( at -0.5 and 0.0 hour) on the test day (Day 22). The mean was obtained from the analysis of covariance (ANCOVA) adjusted for baseline FEV1 and the pooled investigational center. | Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of the assigned study medication and had at least 1 postdose spirometry measurement. | Posted | Mean | Standard Error | percent change | Baseline (Predose at Day 22), 2 hours postdose at Day 22 |
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| Secondary | Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22 | Baseline-adjusted PPFEV1 AUEC0-6 on Study Day 22 was determined using both the Day 1 and Day 22 baselines. | ITT population included all randomized participants who took at least 1 dose of the assigned study medication and had at least 1 postdose spirometry measurement. | Posted | Mean | Standard Error | percentage of predicted FEV1*hour | Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22 |
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Day 1 up to Day 22
Safety population included all randomized participants who received at least 1 dose of their assigned study medication.
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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 | Albuterol-HFA-BAI | Participants received albuterol | 0 | 50 | 0 | 50 | 0 | 50 |
| EG001 | Placebo-HFA-BAI | Participants received placebo | 0 | 45 | 0 | 45 | 0 | 45 |
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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. | 888-483-8279 | USMedInfo@tevapharm.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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| Male |
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| Black |
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| Asian |
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| Other |
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