Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
Multicenter, Double-Blind, Double-Dummy, Randomized, Active-Controlled, Parallel Group Long-Term Safety Study of 15 μg and 25 μg Arformoterol Tartrate Inhalation Solution BID in Subjects With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
443
1 country
60
Brief Summary
To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 chronic-obstructive-pulmonary-disease
Started Oct 2005
Typical duration for phase_3 chronic-obstructive-pulmonary-disease
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 4, 2005
CompletedFirst Posted
Study publicly available on registry
November 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
February 19, 2009
CompletedJune 4, 2012
May 1, 2012
2 years
November 4, 2005
October 3, 2008
May 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations
Percent of participants with the adverse event specified. SOC = system organ class.
Six months
Secondary Outcomes (30)
Number of Participants With New 24-Hour Holter Monitoring Alerts
Visit 6 (week 27)
Number of Participants With Potentially Clinically Significant Glucose Evaluations
visit 6 (week 27)
Number of Participants With Potentially Clinically Significant Potassium Evaluations
visit 6 (week 27)
Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts
visit 6 (week 27)
Inspiratory Capacity Changes From Baseline
weeks 0,3,13,26
- +25 more secondary outcomes
Study Arms (3)
Formoterol 12 ųg 2x/day
ACTIVE COMPARATORArformoterol 15 ųg 2x/day
EXPERIMENTALArformoterol 25 ųg 2x/day
EXPERIMENTALInterventions
Arformoterol 15 ųg BID by nebulization
Arformoterol 25 ųg BID by nebulization
Formoterol fumarate 12 ųg BID via aerolizer/DPI
Placebo nebule or placebo aerolizer
Eligibility Criteria
You may qualify if:
- Male and female subjects must be at least 35 years old at the time of consent
- Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD
- Subjects must have a \>=15 pack-year smoking history and a baseline breathlessness severity grade of \>=2 (Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Visits 1 and 2
- Female subjects \<=65 years of age must have a negative serum pregnancy test, females of childbearing potential must be using an acceptable method of birth control
- Subjects must be in general good health.
You may not qualify if:
- Subjects with a history of asthma, with the exception of asthma diagnosed in childhood
- Subjects with a blood eosinophil count \>5% of total white blood cell count
- Subjects have had a febrile illness within 72 hours (3 days) before Screening Visit 1
- Subjects with a chest x-ray that suggests a diagnosis other than COPD (e.g., diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Unknown Facility
Birmingham, Alabama, United States
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Jasper, Alabama, United States
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Mobile, Alabama, United States
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Little Rock, Arkansas, United States
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Carmichael, California, United States
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Fullerton, California, United States
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Long Beach, California, United States
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Paramount, California, United States
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Rancho Mirage, California, United States
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San Diego, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Hartford, Connecticut, United States
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Bay Pines, Florida, 33744, United States
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Brandon, Florida, United States
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Gainesville, Florida, 32605, United States
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Panama City, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, 30309, United States
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Marietta, Georgia, United States
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Normal, Illinois, United States
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Evansville, Indiana, United States
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Topeka, Kansas, United States
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East Slidell, Louisiana, United States
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Lafayette, Louisiana, United States
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Metairie, Louisiana, United States
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Sunset, Louisiana, United States
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Baltimore, Maryland, United States
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Chester, Maryland, United States
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Wheaton, Maryland, United States
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Ann Arbor, Michigan, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, 63117, United States
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St Louis, Missouri, United States
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Albuquerque, New Mexico, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Statesville, North Carolina, 28625, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Lake Oswego, Oregon, United States
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Medford, Oregon, 97504, United States
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Pittsburgh, Pennsylvania, United States
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Swarthmore, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Simpsonville, South Carolina, United States
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Spartanburg, South Carolina, United States
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Union, South Carolina, 29379, United States
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Knoxville, Tennessee, United States
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Houston, Texas, United States
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Katy, Texas, United States
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San Antonio, Texas, United States
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Danville, Virginia, United States
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Richmond, Virginia, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
Unknown Facility
Morgantown, West Virginia, United States
Related Publications (1)
Hanania NA, Donohue JF, Nelson H, Sciarappa K, Goodwin E, Baumgartner RA, Hanrahan JP. The safety and efficacy of arformoterol and formoterol in COPD. COPD. 2010 Feb;7(1):17-31. doi: 10.3109/15412550903499498.
PMID: 20214460BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Please see dropout rate in participant group. Sunovion is unaware of any other limitations or caveats associated with this study.
Results Point of Contact
- Title
- Respiratory Medical Director
- Organization
- Sepracor Inc.
Study Officials
- STUDY DIRECTOR
Sepracor Medical Director
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2005
First Posted
November 8, 2005
Study Start
October 1, 2005
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
June 4, 2012
Results First Posted
February 19, 2009
Record last verified: 2012-05