- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00685841
A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
November 1, 2012 updated by: Sunovion
A Double-Blind, Double-Dummy, Randomized, Placebo- and Active-Controlled, Multicenter, Parallel-Group Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily compared to placebo in subjects with COPD.
Study Overview
Status
Completed
Conditions
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 subjects were to be randomized in this study.
Study participation consisted of a total of eight (8) study visits over approximately four (4) months for each subject.
This study was previously posted by Sepracor Inc.
In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Study Type
Interventional
Enrollment (Actual)
717
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Jasper, Alabama, United States
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Mobile, Alabama, United States
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Oxford, Alabama, United States
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Arkansas
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Little Rock, Arkansas, United States
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California
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Los Angeles, California, United States
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Mirage, California, United States
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Mission Hills, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Signal Hill, California, United States
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Colorado
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Wheat Ridge, Colorado, United States
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Florida
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Clearwater, Florida, United States
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DeLand, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Pensacola, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Austell, Georgia, United States
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Decatur, Georgia, United States
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Illinois
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Bloomington, Illinois, United States
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Indiana
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Evansville, Indiana, United States
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Kansas
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Shawnee Mission, Kansas, United States
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Minnesota
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Minneapolis, Minnesota, United States
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Missouri
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Charles, Missouri, United States
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Nevada
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Las Vegas, Nevada, United States
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New Jersey
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Margate, New Jersey, United States
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South Bound Brook, New Jersey, United States
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New Mexico
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Alburquerque, New Mexico, United States
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New York
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Endwell, New York, United States
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Ithaca, New York, United States
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New York, New York, United States
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North Carolina
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Spartanburg, North Carolina, United States
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Wilmington, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Oklahoma
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Tulsa, Oklahoma, United States
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Oregon
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Medford, Oregon, United States
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Pennsylvania
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Pittsburg, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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Texas
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Houston, Texas, United States
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Irving, Texas, United States
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San Antonio, Texas, United States
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Virginia
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Chesapeake, Virginia, United States
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Richmond, Virginia, United States
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Washington
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Tacoma, Washington, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A
Arformoterol 50 mcg QD and placebo MDI
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Arformoterol 15 mcg BID
Other Names:
Arformoterol 25 mcg BID
Other Names:
Arformoterol 50 mcg QD
Other Names:
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Experimental: B
Arformoterol 25 mcg BID and placebo MDI
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Arformoterol 15 mcg BID
Other Names:
Arformoterol 25 mcg BID
Other Names:
Arformoterol 50 mcg QD
Other Names:
|
Experimental: C
Arformoterol 15 mcg BID and placebo MDI
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Arformoterol 15 mcg BID
Other Names:
Arformoterol 25 mcg BID
Other Names:
Arformoterol 50 mcg QD
Other Names:
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Active Comparator: D
Salmeterol MDI 42 mcg BID and placebo inhalation solution
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Salmeterol MDI 42 mcg BID
Other Names:
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Placebo Comparator: E
Placebo BID MDI and inhalation solution
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Placebo BID MDI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent change from study baseline FEV1 to the end of the dosing interval (12 hours post-second dose for the BID treatment arms and 24 hours post-dose for the QD treatment arm)
Time Frame: Weeks -2, 0, 3, 6, 9, 12
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Weeks -2, 0, 3, 6, 9, 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time-normalized area under the percent change from visit pre-dose curve for FEV1 over 12 hours (nAUC0-12)
Time Frame: Weeks -2, 0, 3, 6, 9, 12
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Weeks -2, 0, 3, 6, 9, 12
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Peak percent of predicted FEV1
Time Frame: Weeks -2, 0, 3, 6, 9, 12
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Weeks -2, 0, 3, 6, 9, 12
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Time-normalized area under the percent change from study baseline curve for FEV1 over 12 hours (nAUC0-12)
Time Frame: Weeks -2, 0, 3, 6, 9, 12
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Weeks -2, 0, 3, 6, 9, 12
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Time-normalized area under the percent change from study baseline curve for FEV1 over 24 hours (nAUC0-24)
Time Frame: Weeks -2, 0, 3, 6, 9, 12
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Weeks -2, 0, 3, 6, 9, 12
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Timepoint changes in FEV1
Time Frame: Weeks -2, 0, 3, 6, 9, 12
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Weeks -2, 0, 3, 6, 9, 12
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Time to onset of response
Time Frame: Weeks -2, 0, 3, 6, 9, 12
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Weeks -2, 0, 3, 6, 9, 12
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Time to peak change in FEV1
Time Frame: Weeks -2, 0, 3, 6, 9, 12
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Weeks -2, 0, 3, 6, 9, 12
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At-home and in-clinic peak expiratory flow rate (PEFR)
Time Frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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Ipratropium bromide MDI use
Time Frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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Racemic albuterol MDI use
Time Frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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Exacerbations of COPD
Time Frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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COPD symptom ratings (over 12 weeks of treatment)
Time Frame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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Relationship between plasma concentrations of (R,R) formoterol and selected pharmacodynamic parameters
Time Frame: Weeks -2, 0, 3, 6, 9, 12
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Weeks -2, 0, 3, 6, 9, 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2002
Primary Completion (Actual)
June 1, 2003
Study Completion (Actual)
June 1, 2003
Study Registration Dates
First Submitted
May 23, 2008
First Submitted That Met QC Criteria
May 27, 2008
First Posted (Estimate)
May 28, 2008
Study Record Updates
Last Update Posted (Estimate)
November 2, 2012
Last Update Submitted That Met QC Criteria
November 1, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Pharmaceutical Solutions
- Salmeterol Xinafoate
- Formoterol Fumarate
Other Study ID Numbers
- 091-050
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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