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Sponsored by: |
IVAX Research LLC |
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Information provided by: | IVAX Research LLC |
ClinicalTrials.gov Identifier: | NCT00530062 |
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.
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Ages Eligible for Study: | 7 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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. |
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 |
Health Authority: | United States: Food and Drug Administration |
Asthma and Poor Coordinators of Asthma Inhalers |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Albuterol Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Bronchial Diseases Immune System Diseases Adrenergic beta-Agonists Physiological Effects of Drugs Anti-Asthmatic Agents |
Reproductive Control Agents Adrenergic Agonists Pharmacologic Actions Tocolytic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |