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Sponsored by: |
Sepracor, Inc. |
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Information provided by: | Sepracor, Inc. |
ClinicalTrials.gov Identifier: | NCT00685529 |
The purpose of this study is to compare the blood levels of arformoterol tartrate inhalation solution to racemic formoterol in male and female subjects with mild to moderate Chronic Obstructive Pulmonary Disease (COPD).
Condition | Intervention | Phase |
---|---|---|
COPD |
Drug: Racemic formoterol Drug: Arformoterol tartrate inhalation solution |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Randomized, Multiple Dose, 3-Way Crossover Study of Arformoterol Tartrate Inhalation Solution and Foradil® (Racemic Formoterol) in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) |
Enrollment: | 24 |
Study Start Date: | April 2005 |
Study Completion Date: | October 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
12 µg of racemic formoterol fumarate BID
|
Drug: Racemic formoterol
12 µg of racemic formoterol fumarate BID
|
B: Experimental
15 µg of nebulized arformoterol tartrate inhalation solution BID
|
Drug: Arformoterol tartrate inhalation solution
15 µg of nebulized arformoterol tartrate inhalation solution BID
|
C: Active Comparator
24 µg of racemic formoterol fumarate BID
|
Drug: Racemic formoterol
24 µg of racemic formoterol fumarate BID
|
This is an open label, randomized, multiple dose, 3-way crossover, multicenter, inpatient and outpatient study to compare the pharmacokinetic (PK) profile of arformoterol tartrate inhalation solution and Foradil® in male and female subjects with mild to moderate COPD. Up to 36 subjects (with a minimum 40% of each gender) were to be randomized to ensure that at minimum 24 subjects completed the study. The study included 3 dose periods and 3 washout periods. Subjects received 3 different treatments in random order for 13 consecutive days and a single dose on the morning of the 14th day.
Subjects will be randomly assigned to 1 of the 6 possible treatment sequences. During each dose period, subjects received medication via nebulization or DPI twice daily for 13 consecutive days and a single dose on the morning of the 14th day. There was be a 10 day washout period between each treatment.
Subject participation was be approximately 13 weeks and included a screening visit and 7 study visits.
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Long Beach, California, United States | |
United States, Florida | |
Fort Lauderdale, Florida, United States | |
United States, North Carolina | |
Raleigh, North Carolina, United States | |
United States, South Carolina | |
Spartanburg, South Carolina, United States | |
Simpsonville, South Carolina, United States | |
United States, Washington | |
Spokane, Washington, United States |
Responsible Party: | Sepracor Inc. ( Brovana Medical Director ) |
Study ID Numbers: | 091-019 |
Study First Received: | May 23, 2008 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00685529 History of Changes |
Health Authority: | United States: Food and Drug Administration |
COPD Arformoterol formoterol |
Neurotransmitter Agents Lung Diseases, Obstructive Adrenergic beta-Agonists Adrenergic Agents Respiratory Tract Diseases Lung Diseases |
Anti-Asthmatic Agents Formoterol Peripheral Nervous System Agents Bronchodilator Agents Adrenergic Agonists Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Adrenergic Agonists Pharmacologic Actions |
Lung Diseases, Obstructive Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Formoterol Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |