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This is a study of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects birth to ≤ 48 months of age who go to the Emergency Department (ED) or their physician's office with an acute bronchospasm. Subjects presenting to the ED or physician's office with an acute bronchospasm must have a history of reactive airways disease, based on subjects' parent/guardian report.
This is a study to determine the safety and tolerability of cumulative dosing with levalbuterol tartrate HFA inhalation aerosol MDI using a valved holding chamber and facemask in pediatric subjects birth to ≤ 48 months of age with acute bronchospasm. It is a randomized, double-blind, parallel-group, multicenter, trial of 3 doses of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects birth to ≤ 48 months of age who present to either the Emergency Department (ED) or their physician's office with an acute bronchospasm. Subjects presenting to the ED or physician's office with an acute bronchospasm must have a history of reactive airways disease, based on subjects' parent/guardian report.
Eligible subjects whose parent(s) or legal guardian(s) provide written informed consent to participate will be randomized to 1 of 2 treatments. Treatment 1 consists of 3 doses, with each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA [cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol]); Treatment 2 consists of 3 doses, with each dose comprised of 8 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff [cumulative dose of 1080 mcg of levalbuterol tartrate HFA inhalation aerosol]). For each Treatment, study medication will be administered every 20 minutes over a period of 1 hour for three doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levalbuterol tartrate HFA inhalation aerosol plus placebo HFA | Experimental | Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol |
|
| levalbuterol tartrate HFA inhalation aerosol plus levalbuterol | Experimental | Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levalbuterol tartrate HFA inhalation aerosol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events. | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Week 1 |
| The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events. | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Week 1 |
| The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation. | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pulmonary Score (Total Score) to End of Treatment | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Respiratory Medical Director, MD | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Score Physician Alliance, LLC | St. Petersburg | Florida | 33710 | United States | ||
| Northern Illinios Research Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol levalbuterol tartrate HFA inhalation aerosol placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug |
|
| Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment |
Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. |
| Day 1 |
| Change From Baseline in Pulmonary Score (Total Score) After Each Dose | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | 20 minutes, 40 minutes, 60 minutes |
| Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | 20 minutes, 40 minutes, 60 minutes |
| Number and Percentage of Subjects Determined to be Stabilized After Treatment | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Day 1 |
| DeKalb |
| Illinois |
| 60115 |
| United States |
| Northern Illinois Associates | DeKalb | Illinois | 60115 | United States |
| Michael W. Simon, MD, PSC | Nicholasville | Kentucky | 40356 | United States |
| Willis-Knighton Physician Network / Portico Pediatrics | Shreveport | Louisiana | 71105 | United States |
| Mid Michigan Sleep Center | Grand Blanc | Michigan | 48439 | United States |
| Craig Spiegel, MD | Bridgeton | Missouri | 63044 | United States |
| St. Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Capital Pediatrics & Adolescent Center PLLC | Raleigh | North Carolina | 27609 | United States |
| Capitol Pediatric & Adolescent Center PLLC | Raleigh | North Carolina | 27609 | United States |
| Dayton Clinical Research | Dayton | Ohio | 45406 | United States |
| Charleston Allergy & Asthma Research | Summerville | South Carolina | 29485 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| TTS Research | Boerne | Texas | 78006 | United States |
| Allergy Asthma Research Institute | Waco | Texas | 76712 | United States |
| PI-Coor Clinical Research | Burke | Virginia | 22015 | United States |
| Advanced Pediatrics | Vienna | Virginia | 22180 | United States |
| FG001 |
| Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol |
Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol. levalbuterol tartrate HFA inhalation aerosol |
| COMPLETED |
|
| NOT COMPLETED |
|
Pediatric subjects birth to less than or equal to 48 months of age with reactive airways disease in an acute setting
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| ID | Title | Description |
|---|---|---|
| BG000 | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol levalbuterol tartrate HFA inhalation aerosol placebo |
| BG001 | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol. levalbuterol tartrate HFA inhalation aerosol |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events. | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Posted | Number | Number of Adverse Events | Week 1 |
|
|
| ||||||||||||||||||||||||||||||
| Primary | The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events. | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Posted | Number | Number of Serious Adverse Events | Week 1 |
|
| |||||||||||||||||||||||||||||||
| Primary | The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation. | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Posted | Number | Number of Discontinuations | Week 1 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pulmonary Score (Total Score) to End of Treatment | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Posted | Day 1 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Posted | Day 1 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pulmonary Score (Total Score) After Each Dose | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Posted | 20 minutes, 40 minutes, 60 minutes |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Posted | 20 minutes, 40 minutes, 60 minutes |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Subjects Determined to be Stabilized After Treatment | Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided. | Posted | Day 1 |
|
|
three months
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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 | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA | Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol levalbuterol tartrate HFA inhalation aerosol placebo | 0 | 9 | 2 | 9 | ||
| EG001 | Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol | Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol. levalbuterol tartrate HFA inhalation aerosol | 0 | 9 | 2 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Existaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Termor | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
In the event the Study is part of a multi-center study, the first publication of the results of the study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Respiratory Medical Director | Sunovion Pharmaceuticals Inc. | 1-866-503-6351 | clinicaltrialsdisclousre@sunovion.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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| >=65 years |
|
| Male |
|
| Participants |
|
|
| Counts |
|---|
| Participants |
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