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| Sponsored by: |
Teva Global Respiratory Research LLC |
|---|---|
| Information provided by: | Teva Global Respiratory Research LLC |
| ClinicalTrials.gov Identifier: | NCT00530062 |
Purpose
This is a research study designed to compare the single-dose effectiveness of albuterol-HFA-BAI (breath activated inhaler) and albuterol-HFA-MDI (metered dose inhaler) in asthmatics with poor inhaler coordinating abilities. Patients must be 7 to 70 years of age to participate in this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Albuterol-HFA-MDI Drug: Albuterol-HFA-BAI |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Crossover Assignment |
| Official Title: | Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI/MDI in Asthmatics |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | August 2008 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Albuterol Inhaler
|
Drug: Albuterol-HFA-MDI
Inhalation Aerosols, 90 mcg, 1 dose per treatment period
|
|
2: Active Comparator
Albuterol Inhaler
|
Drug: Albuterol-HFA-BAI
Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.
|
Eligibility| Ages Eligible for Study: | 7 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tirsa M Torres, MSEd | 305-575-6229 | Tirsa.Torres@tevaneuro.com |
| United States, California | |
| Pediatric Care Medical Group, Inc. | Recruiting |
| Huntington Beach, California, United States, 92647 | |
| Contact: Tirsa Torres 305-575-6229 | |
| United States, Colorado | |
| Colorado Allergy and Asthma Centers, PC | Recruiting |
| Lakewood, Colorado, United States, 80401 | |
| Contact: Tirsa Torres 305-575-6229 | |
| United States, Minnesota | |
| Clinical Research Institute, Inc. | Recruiting |
| Minneapolis, Minnesota, United States, 55402 | |
| Contact: Tirsa Torres 305-575-6229 | |
| United States, Oklahoma | |
| Allergy, Asthma, & Clinical Research Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73120 | |
| Contact: Tirsa Torres 305-575-6229 | |
| United States, Oregon | |
| Allergy, Asthma, and Dermatology Research Center, LLC | Recruiting |
| Lake Oswego, Oregon, United States, 97035 | |
| Contact: Tirsa Torres 305-575-6229 | |
| Principal Investigator: | James W Baker, MD | Allergy, Asthma, and Dermatology Research Center, LLC |
| Principal Investigator: | Grant C Olson, MD | Colorado Allergy and Asthma Centers, PC |
| Principal Investigator: | Paul Qaqundah, MD | Pediatric Care Medical Group, Inc. |
More Information
| Responsible Party: | IVAX Research, LLC ( Tirsa Torres ) |
| Study ID Numbers: | IXR-404-04-167 |
| Study First Received: | September 14, 2007 |
| Last Updated: | August 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00530062 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma and Poor Coordinators of Asthma Inhalers |
|
Neurotransmitter Agents Adrenergic beta-Agonists Bronchial Diseases Adrenergic Agents Albuterol Asthma Anti-Asthmatic Agents Adrenergic Agonists |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
|
Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Albuterol Physiological Effects of Drugs Reproductive Control Agents Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Tocolytic Agents |
Therapeutic Uses Immune System Diseases Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |