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Sponsored by: |
Sepracor, Inc. |
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Information provided by: | Sepracor, Inc. |
ClinicalTrials.gov Identifier: | NCT00583986 |
This is a study to investigate the reliability, ruggedness and safety of the top mounted actuation indicator (TMAI) when used with Levalbuterol HFA MDI.
Condition | Intervention | Phase |
---|---|---|
Asthma Chronic Obstructive Pulmonary Disease COPD |
Drug: Levalbuterol HFA MDI with top mounted actuation indicator |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Study to Determine the Reliability of a Top Mount Actuation Indicator When Used With Levalbuterol Tartrate HFA MDI in Adult and Pediatric Subjects With Asthma or Chronic Obstructive Pulmonary Disease |
Enrollment: | 150 |
Study Start Date: | September 2005 |
Study Completion Date: | March 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Levalbuterol HFA MDI with top mounted actuation indicator
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Drug: Levalbuterol HFA MDI with top mounted actuation indicator
Levalbuterol HFA MDA with top mounted actuation indicator
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This is an open-label, multicenter, TMAI study with Levalbuterol HFA MDI in adult and pediatric subjects with asthma or COPD. Period I: One week, open-label, run-in period during which subjects must have asthma or COPD symptoms requiring use of, as needed, Levalbuterol HFA MDI(without TMAI) on at least half of the days [4-12 actuations on a single day]. Period II: Nine week, open-label period during which subjects will use the Levalbuterol HFA MDI with TMAI PRN. The total study duration for a subject will not exceed 10 weeks.
Ages Eligible for Study: | 4 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | John Hanrahan, M.D. | Sepracor, Inc. |
Responsible Party: | Sepracor Inc. ( Xopenex Medical Director ) |
Study ID Numbers: | 051-357 |
Study First Received: | December 21, 2007 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00583986 |
Health Authority: | United States: Food and Drug Administration |
top mounted actuation indicator Asthma COPD Chronic Obstructive Pulmonary Disease |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Albuterol |
Respiration Disorders Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity Pulmonary Disease, Chronic Obstructive |
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 |