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Sponsored by: |
Sepracor, Inc. |
---|---|
Information provided by: | Sepracor, Inc. |
ClinicalTrials.gov Identifier: | NCT00571428 |
To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease |
Drug: Arformoterol Tartrate Inhalation Solution |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study |
Official Title: | Modified-Blind, Randomized, Multicenter, Single Dose, Two-Way Crossover Study of Arformoterol Tartrate Inhalation Solution 15μg BID vs. 30μg QD in Subjects With(COPD) |
Enrollment: | 33 |
Study Start Date: | November 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
A: Arformoterol 30 μg QD
|
Drug: Arformoterol Tartrate Inhalation Solution
A.30/4ml QD B.15ug/2ml BID |
B: Active Comparator
B. Arformoterol 15 ųg BID
|
Drug: Arformoterol Tartrate Inhalation Solution
A.30/4ml QD B.15ug/2ml BID |
This is a modified blind, randomized, multicenter, single dose two-way crossover study to assess the efficacy and safety of arformoterol 15μg BID versus arformoterol 30μg QD in subjects with COPD. Subject participation will last approximately three weeks and will include a screening visit, two 24-hour visits, and a follow up telephone call.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Oregon | |
Medford, Oregon, United States, 97504 | |
Portland, Oregon, United States, 97213 | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, South Carolina | |
Spartanburg, South Carolina, United States, 29303 |
Study Director: | Pulmonary Medical Director | Sepracor, Inc. |
Responsible Party: | Sepracor Inc. ( Brovana Medical Director ) |
Study ID Numbers: | 091-903 |
Study First Received: | December 10, 2007 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00571428 |
Health Authority: | United States: Food and Drug Administration |
COPD Chronic Bronchitis Emphysema |
Emphysema Pulmonary Emphysema Naphazoline Bronchitis, Chronic Oxymetazoline Lung Diseases, Obstructive Respiratory Tract Diseases |
Guaifenesin Phenylephrine Lung Diseases Formoterol Bronchitis Phenylpropanolamine 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 Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |