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Sponsors and Collaborators: |
University of California, Los Angeles Dey, L.P. |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00633776 |
The purpose of this study is to compare the effects of nebulized formoterol fumarate (Perforomist) to dry-powder inhaler formoterol fumarate (Foradil). Perforomist is a solution that is made into very fine spray (using a nebulizer) that is then breathed in over 10-15 minutes. Foradil is taken in a single quick, deep inhalation.
Condition | Intervention | Phase |
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Chronic Obstructive Pulmonary Disease COPD Chronic Bronchitis Emphysema |
Drug: formoterol fumarate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Perforomist Versus Foradil Evaluated by Inspiratory Capacity and HRCT |
Estimated Enrollment: | 20 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Formoterol fumarate 20 mcg (Perforomist) nebulized via Pari C nebulizer at Test Visit 1; Formoterol 12 mcg (Foradil) via aerosolizer dry powder inhaler at Test Visit 2
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Drug: formoterol fumarate
Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment
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2: Active Comparator
Formoterol fumarate 12 mcg (Foradil) via aerosolizer dry powder inhaler at Test Visit 1; Formoterol fumarate 20 mcg (Perforomist) nebulized via Pari C nebulizer at Test Visit 2
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Drug: formoterol fumarate
Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment
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Participation requires 3 visits over 1-5 weeks. The first visit (Screening) will help determine subjects' eligibility through medical history, physical exam, lung function testing, and exercise testing. Those who qualify will be invited back to 2 test visits, at which subjects will undergo lung function testing and high-resolution CT scans before and after treatment with one of the study drugs. All subjects will take both study drugs: those who are randomized to Perforomist at Test Visit 1 will take Foradil at Test Visit 2, and vice versa.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCLA David Geffen School of Medicine | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Donald P Tashkin, M.D. | UCLA David Geffen School of Medicine |
Study Director: | Eric Kleerup, M.D. | UCLA David Geffen School of Medicine |
Responsible Party: | University of California, Los Angeles (UCLA) David Geffen School of Medicine ( Donald Tashkin, M.D. ) |
Study ID Numbers: | Perforomist CT Study |
Study First Received: | March 4, 2008 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00633776 History of Changes |
Health Authority: | United States: Institutional Review Board |
Chronic Obstructive Pulmonary Disease COPD Chronic bronchitis Emphysema |
Perforomist Foradil CT lung function |
Emphysema Neurotransmitter Agents Adrenergic beta-Agonists Bronchial Diseases Adrenergic Agents Respiration Disorders Anti-Asthmatic Agents Adrenergic Agonists Pulmonary Emphysema Bronchitis, Chronic |
Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Formoterol Bronchitis Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Pulmonary Emphysema Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses |
Formoterol Bronchitis Emphysema Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Pharmacologic Actions Bronchitis, Chronic Autonomic Agents Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |