Status:
COMPLETED
A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
COPD
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief Summary
A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily compared to placebo in subjects with COPD.
Detailed Description
This study is a double-blind, double-dummy, randomized, placebo- and active-controlled, multicenter, parallel-group study of adult subjects with a primary clinical diagnosis of COPD. Approximately 800...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subject may be male or female and must be aged less than or equal to 35 years on the day the informed consent is signed.
- 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.
- Subject must be able to complete all study questionnaires and logs reliably. Exclusion Criteria
- Female subject who is pregnant or lactating.
- 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).
Exclusion
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
717 Patients enrolled
Trial Details
Trial ID
NCT00685841
Start Date
February 1 2002
End Date
June 1 2003
Last Update
November 2 2012
Active Locations (52)
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1
Anniston, Alabama, United States
2
Birmingham, Alabama, United States
3
Jasper, Alabama, United States
4
Mobile, Alabama, United States