A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00685841
Last Updated: 2012-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
717 participants
INTERVENTIONAL
2002-02-28
2003-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Arformoterol 50 mcg QD and placebo MDI
Arformoterol tartrate inhalation solution
Arformoterol 50 mcg QD
B
Arformoterol 25 mcg BID and placebo MDI
Arformoterol tartrate inhalation solution
Arformoterol 25 mcg BID
C
Arformoterol 15 mcg BID and placebo MDI
Arformoterol tartrate inhalation solution
Arformoterol 15 mcg BID
D
Salmeterol MDI 42 mcg BID and placebo inhalation solution
Salmeterol MDI
Salmeterol MDI 42 mcg BID
E
Placebo BID MDI and inhalation solution
Placebo
Placebo BID MDI
Interventions
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Arformoterol tartrate inhalation solution
Arformoterol 50 mcg QD
Arformoterol tartrate inhalation solution
Arformoterol 25 mcg BID
Arformoterol tartrate inhalation solution
Arformoterol 15 mcg BID
Salmeterol MDI
Salmeterol MDI 42 mcg BID
Placebo
Placebo BID MDI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female subjects greater than or equal to 65 years of age must have a serum pregnancy test conducted at Visit 1 and confirmed negative prior to randomization. Subjects of childbearing potential must be using an acceptable method of birth control.
* Female subjects who are considered not of childbearing potential must be:
* documented surgically sterile (defined as status post-hysterectomy or bilateral tubal ligation) OR
* postmenopausal
* Subject must have a primary diagnosis of COPD, which may include components of chronic bronchitis and/or emphysema. Diagnosis can be made during the screening process.
* Subject must have a minimum smoking history of 15 pack-years (pack-years = the number of cigarette packs per day times the number of years).
* Subject must have a chest x-ray that is consistent with the diagnosis of COPD (e.g., not diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions) and taken less than or equal to 3 months prior to study start. If there is no chest x-ray taken less than or equal to 3 months prior to study start, or if recent results are unavailable for review, a chest x-ray will be performed.
Exclusion Criteria
* Subject who has participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another investigational drug study.
* Subject whose schedule or travel prevents the completion of all required visits.
* Subject who is scheduled for in-patient hospitalization, including elective surgery (in patient or out-patient) during the trial.
* Subject with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to study start.
* Subject with a known history of asthma or any chronic respiratory disease (including a current history of sleep apnea) other than COPD (chronic bronchitis and/or emphysema).
* Subject with a history of cancer except non-melanomatous skin cancer. Subjects with a history of cancer that is considered surgically cured and without a recurrence within the past 10 years may participate in the study. History of hematologic/lymphatic malignancy treated with chemotherapy or radiation is not allowed.
* Subject with a history of lung resection of more than one full lobe.
* Subject who requires continuous supplemental oxygen therapy (unless subject resides at elevation greater than or equal to 4,000 feet).
* Subject who has had a change in dose or type of any medications for COPD within 14 days prior to the screening visit.
* Subject with a known sensitivity to (R,R)-formoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations.
* Subject with a history of substance abuse or drug abuse within 12 months of study start, or with a positive urine drug screen at study start.
* Subject using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers).
35 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Locations
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Anniston, Alabama, United States
Birmingham, Alabama, United States
Jasper, Alabama, United States
Mobile, Alabama, United States
Oxford, Alabama, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Mirage, California, United States
Mission Hills, California, United States
San Diego, California, United States
Santa Ana, California, United States
Signal Hill, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Wheat Ridge, Colorado, United States
Clearwater, Florida, United States
DeLand, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Pensacola, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Austell, Georgia, United States
Decatur, Georgia, United States
Bloomington, Illinois, United States
Evansville, Indiana, United States
Shawnee Mission, Kansas, United States
Minneapolis, Minnesota, United States
Charles, Missouri, United States
Las Vegas, Nevada, United States
Margate City, New Jersey, United States
South Bound Brook, New Jersey, United States
Albuquerque, New Mexico, United States
Endwell, New York, United States
Ithaca, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Spartanburg, North Carolina, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Houston, Texas, United States
Irving, Texas, United States
San Antonio, Texas, United States
Chesapeake, Virginia, United States
Richmond, Virginia, United States
Tacoma, Washington, United States
Countries
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Other Identifiers
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091-050
Identifier Type: -
Identifier Source: org_study_id