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| Sponsor: | Teva Branded Pharmaceutical Products, R&D Inc. |
|---|---|
| Information provided by: | Teva Branded Pharmaceutical Products, R&D Inc. |
| ClinicalTrials.gov Identifier: | NCT00308685 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Albuterol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Eligibility| Ages Eligible for Study: | 4 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arkansas | |
| Little Rock Allergy and Asthma | |
| Little Rock, Arkansas, United States, 72205-4565 | |
| United States, California | |
| Allergy & Asthma Specialist Medical Group | |
| Huntington Beach, California, United States, 92647 | |
| Allergy & Asthma Associates of Santa Clara Valley Research Center | |
| San Jose, California, United States, 95117 | |
| United States, Colorado | |
| William Storms Medical Research | |
| Colorado Springs, Colorado, United States, 80907 | |
| Colorado Allergy and Asthma Centers, PC | |
| Denver, Colorado, United States, 80230 | |
| Colorado Allergy and Asthma Centers, PC | |
| Englewood, Colorado, United States, 80112 | |
| Colorado Allergy and Asthma Centers, PC | |
| Lakewood, Colorado, United States, 80401 | |
| United States, Georgia | |
| Southern Allergy & Asthma, PC | |
| Savannah, Georgia, United States, 31405 | |
| United States, Illinois | |
| Sneeze, Wheeze & Itch Associates, Inc. | |
| Normal, Illinois, United States, 61761 | |
| United States, Minnesota | |
| Clinical Research Institute | |
| Minneapolis, Minnesota, United States, 55402 | |
| United States, Nebraska | |
| The Asthma & Allergy Center, PC | |
| Papillion, Nebraska, United States, 68046 | |
| United States, Ohio | |
| Allergy and Respiratory Center | |
| Canton, Ohio, United States, 44718 | |
| United States, Oklahoma | |
| Allergy, Asthma & Clinical Research Center | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Texas | |
| Pediatric Pulmonary Associates of North Texas | |
| Dallas, Texas, United States, 75230 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00308685 History of Changes |
| Other Study ID Numbers: | IXR-303-25-167 |
| Study First Received: | March 28, 2006 |
| Last Updated: | December 15, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma Pediatric asthma |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol Bronchodilator Agents Tocolytic Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |