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| Sponsor: | 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 and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability |
| Enrollment: | 49 |
| Study Start Date: | January 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
BAI: Active Comparator
Albuterol Hydrofluoroalkane (HFA) Breath-Actuated Inhaler (BAI)
|
Drug: Albuterol-HFA-BAI
Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.
|
|
MDI: Active Comparator
Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)
|
Drug: Albuterol-HFA-MDI
Inhalation Aerosols, 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| United States, California | |
| Clinical Study Site | |
| Huntington Beach, California, United States, 92647 | |
| United States, Colorado | |
| Teva Clinical Study Site | |
| Lakewood, Colorado, United States, 80401 | |
| United States, Minnesota | |
| Clinical Study Site | |
| Minneapolis, Minnesota, United States, 55402 | |
| United States, Oklahoma | |
| Clinical Study Site | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Oregon | |
| Clinical Study Site | |
| Lake Oswego, Oregon, United States, 97035 | |
| Study Chair: | Clinical Study Leader | Teva Global Respiratory Research LLC |
More Information
| Responsible Party: | Teva Global Respiratory Research, LLC ( Clinical Study Leader ) |
| Study ID Numbers: | IXR-404-04-167 |
| Study First Received: | September 14, 2007 |
| Last Updated: | September 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00530062 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma and Poor Coordinators of Asthma Inhalers |
|
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 |