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The purpose of this study is to compare the efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old.
A double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in pediatric subjects presenting with acute reactive airways disease. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Low dose levalbuterol (0.15 mg, 0.31 mg or 0.63 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion. Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID). |
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| B | Experimental | High dose levalbuterol (0.31 mg, 0.63 mg or 1.25 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion. Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID). |
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| C | Active Comparator | Racemic albuterol (0.63, 1.25 mg or 2.5 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion. Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levalbuterol HCl Inhalation Solution | Drug | Nebulized unit dose vial for inhalation, low dose (0.15 mg, 0.31 mg or 0.63 mg), adjusted for body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum decrease in Respiratory Status Scale© total score | Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged |
| Measure | Description | Time Frame |
|---|---|---|
| Time to meet discharge criteria or clinical decision to discharge. | Days 0-7 | |
| Time to maximum decrease in Respiratory Status Scale© total score. | Days 0-7 | |
| Individual Respiratory Status Scale© items. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
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|
| Levalbuterol HCl Inhalation Solution | Drug | Nebulized unit dose vial for inhalation, high dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight |
|
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| Albuterol HCl Inhalation Solution | Drug | Nebulized unit dose vial for inhalation, dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight |
|
|
| Days 0-7 |
| Time to hospitalization. | Days 0-7 |
| Rate of hospitalization. | Days 0-7 |
| Corona |
| California |
| United States |
| Englewood | California | United States |
| Huntington Beach | California | United States |
| Long Beach | California | United States |
| Sacramento | California | United States |
| San Diego | California | United States |
| Denver | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Lake Worth | Florida | United States |
| Tampa | Florida | United States |
| Bloomington | Illinois | United States |
| Chicago | Illinois | United States |
| Indianapolis | Indiana | United States |
| Lexington | Kentucky | United States |
| Louisville | Kentucky | United States |
| Marrero | Louisiana | United States |
| Shreveport | Louisiana | United States |
| Omaha | Nebraska | United States |
| New York | New York | United States |
| Raleigh | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Oswego | Ohio | United States |
| Medford | Oregon | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Burke | Virginia | United States |
| Norfolk | Virginia | United States |
| Charleston | West Virginia | United States |
| Halifax | Nova Scotia | Canada |
| Saskatoon | Saskatchewan | Canada |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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