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Sponsors and Collaborators: |
University of Florida IVAX Research LLC |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00643578 |
The purpose of this study is to find out whether a difference between two doses of formoterol can be detected by methacholine challenge.
Condition | Intervention |
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Asthma |
Procedure: formoterol |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Pharmacodynamics Study |
Official Title: | A Pilot Study to Evaluate the Dose-Response of Inhaled Formoterol to Inhibit Airway Responsiveness to Methacholine in Patients With Mild Asthma |
Estimated Enrollment: | 10 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
a single dose of 24 mcg of formoterol
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Procedure: formoterol
a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
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1: Active Comparator
a single dose of 12 mcg of formoterol
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Procedure: formoterol
a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
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During the screening visit, subjects'vital signs (heart rate, blood pressure and temperature) will be measured and they will perform standard spirometry. If the results of this test are 70% of normal or greater, they will be examined by a physician, and blood (1 teaspoonful) and urine will be collected for routine laboratory tests (CBC and routine urinalysis). If they are a female, a pregnancy test will be performed.
During the second visit, subjects will inhale 1 or 2 doses of formoterol, (Foradil Aerolizer 12 mcg/capsule) a long-acting bronchodilator and 1 hour later, perform a methacholine test.
At the end of the methacholine test, they will be given albuterol to reverse the effects of methacholine. On the third study day, they will repeat the second visit but with the opposite dose of Foradil.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carmen Lowell, RRT | 352-273-6183 | carmen@cop.ufl.edu |
United States, Florida | |
University of Florida Asthma Research Lab | |
Gainesville, Florida, United States, 32610-0486 |
Principal Investigator: | Leslie Hendeles, PharmD | University of Florida |
Responsible Party: | University of Florida ( Leslie Hendeles, Pharm.D., Professor, Pharmacy and Pediatrics ) |
Study ID Numbers: | Ivax-65307 |
Study First Received: | March 20, 2008 |
Last Updated: | March 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00643578 |
Health Authority: | United States: Food and Drug Administration |
formoterol methacholine challenge |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Methacholine Chloride |
Hypersensitivity, Immediate Formoterol Asthma Respiratory Hypersensitivity |
Parasympathomimetics Respiratory System Agents Neurotransmitter Agents Cholinergic Agonists Bronchial Diseases Immune System Diseases Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Bronchoconstrictor Agents Miotics |
Physiological Effects of Drugs Anti-Asthmatic Agents Cholinergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Muscarinic Agonists Peripheral Nervous System Agents Bronchodilator Agents |