A Dose Ranging Study of Arformoterol Given Once Daily Compared to Arformoterol Given Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
February 21, 2012 updated by: Sunovion
A Double-blind, Randomized, Multicenter, Two-part Parallel-group, Dose-ranging Study of Twice-daily and Once-daily (R,R) Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A dose ranging study to evaluate the safety, tolerability and efficacy of arformoterol (given once or twice a day) in subjects with COPD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Drug: Arformoterol tartrate inhalation solution
- Drug: Arformoterol tartrate inhalation solution
- Drug: Arformoterol tartrate inhalation solution
- Drug: Arformoterol tartrate inhalation solution
- Drug: Arformoterol tartrate inhalation solution
- Drug: Arformoterol tartrate inhalation solution
- Drug: Placebo
- Drug: Placebo
Detailed Description
This study is a double-blind, repeat-dose, randomized, multicenter, two-part, parallel-group, dose-ranging study of arformoterol and placebo in the treatment of subjects with COPD.
Approximately 215 subjects will be randomized in this study.
Study participation will consist of a total of eight (8) study visits over approximately ten (10) weeks 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)
215
Phase
- Phase 2
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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California
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Encinitas, California, United States
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Long Beach, California, United States
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Florida
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Brandon, Florida, United States
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Cleawater, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Port Orange, Florida, United States
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West Palm Beach, Florida, United States
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Georgia
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Austell, Georgia, United States
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Kansas
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Topeka, Kansas, United States
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Louisiana
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Marrero, Louisiana, United States
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New Orleans, Louisiana, United States
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Opelousas, Louisiana, United States
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Nebraska
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McCook, Nebraska, United States
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New Jersey
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Princeton, New Jersey, United States
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North Carolina
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Hickory, North Carolina, United States
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Statesville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Ohio
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Columbus, Ohio, United States
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Oregon
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Eugene, Oregon, United States
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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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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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Texas
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Austin, Texas, United States
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San Antonio, Texas, United States
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Washington
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Renton, Washington, United States
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Spokane, Washington, United States
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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 greater than or equal to 35 years on the day the informed consent is signed.
- Female subject less than or equal to 65 years of age must have a serum pregnancy test conducted at study start and confirmed negative. Subjects of childbearing potential must be using an acceptable method of birth control and agree to continue its use throughout the study.
In order to be considered not of childbearing potential female subjects 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) and taken less than or equal to 6 months before study start. If there is no chest x-ray taken less than or equal to 6 months before study start, a chest x-ray will be performed at Visit 1.
- Subject must be able to complete all study questionnaires and logs reliably.
Exclusion Criteria:
- A female 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's schedule or travel prevents the completion of all required visits.
- Subject is scheduled for in-patient hospitalization, including elective surgery (in patient or out-patient) during the trial.
- Subject has had a life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the 30 days prior to study start.
- Subject has a known history of asthma (except childhood asthma) or any chronic respiratory disease (including a current history of sleep apnea) other than COPD (chronic bronchitis and/or emphysema).
- Subject has a known history of alpha 1 antitrypsin deficiency-related emphysema.
- Subject has a history of cancer except non-melanoma skin cancer. Subjects with a history of cancer that is considered surgically cured and without a recurrence within the past 5 years may participate in the study. History of hematologic/lymphatic malignancy treated with chemotherapy or radiation is not allowed, under any condition.
- Subject has a history of lung resection of more than one full lobe or being a recipient of a lung or major organ transplant.
- Subject requires continuous supplemental oxygen therapy (unless subject resides at elevation greater than or equal to 4,000 feet).
- Subject has had a change in dose or type of any medications for COPD within 14 days before the screening visit.
- Subject has a known sensitivity to arformoterol, ipratropium or albuterol or any of the excipients contained in any of these formulations.
- Subject has a history of substance abuse within 12 months of Visit 1, or with a positive urine drug screen at study start.
- Subject is using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers).
- Subject has had significant blood loss (>500 cc) or donated blood within 60 days preceding screening or plans to donate blood during or within 60 days after completing the study.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: A1
Arformoterol 5 mcg BID for 14 days
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Arformoterol 5 mcg BID
Other Names:
Arformoterol 15 mcg BID
Other Names:
Arformoterol 25 mcg BID
Other Names:
Arformoterol 15 mcg QD
Other Names:
Arformoterol 25 mcg QD
Other Names:
Arformoterol 50 mcg QD
Other Names:
|
|
Experimental: A2
Arformoterol 15 mcg BID for 14 days
|
Arformoterol 5 mcg BID
Other Names:
Arformoterol 15 mcg BID
Other Names:
Arformoterol 25 mcg BID
Other Names:
Arformoterol 15 mcg QD
Other Names:
Arformoterol 25 mcg QD
Other Names:
Arformoterol 50 mcg QD
Other Names:
|
|
Experimental: A3
Arformoterol 25 mcg BID for 14 days
|
Arformoterol 5 mcg BID
Other Names:
Arformoterol 15 mcg BID
Other Names:
Arformoterol 25 mcg BID
Other Names:
Arformoterol 15 mcg QD
Other Names:
Arformoterol 25 mcg QD
Other Names:
Arformoterol 50 mcg QD
Other Names:
|
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Placebo Comparator: A4
Placebo inhalation solution BID for 14 days
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Placebo inhalation solution BID
Placebo inhalation solution QD
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Experimental: B1
Arformoterol 15 mcg QD for 14 days
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Arformoterol 5 mcg BID
Other Names:
Arformoterol 15 mcg BID
Other Names:
Arformoterol 25 mcg BID
Other Names:
Arformoterol 15 mcg QD
Other Names:
Arformoterol 25 mcg QD
Other Names:
Arformoterol 50 mcg QD
Other Names:
|
|
Experimental: B2
Arformoterol 25 mcg QD for 14 days
|
Arformoterol 5 mcg BID
Other Names:
Arformoterol 15 mcg BID
Other Names:
Arformoterol 25 mcg BID
Other Names:
Arformoterol 15 mcg QD
Other Names:
Arformoterol 25 mcg QD
Other Names:
Arformoterol 50 mcg QD
Other Names:
|
|
Experimental: B3
Arformoterol 50 mcg QD for 14 days
|
Arformoterol 5 mcg BID
Other Names:
Arformoterol 15 mcg BID
Other Names:
Arformoterol 25 mcg BID
Other Names:
Arformoterol 15 mcg QD
Other Names:
Arformoterol 25 mcg QD
Other Names:
Arformoterol 50 mcg QD
Other Names:
|
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Placebo Comparator: B4
Placebo inhalation solution QD for 14 days
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Placebo inhalation solution BID
Placebo inhalation solution QD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Part A: The primary efficacy endpoint is the time-normalized area under the FEV1 percent change from pre-dose curve over 12 hours (nAUC0-12) after the first (AM) dose at the 24 hour clinic visit (Visit 4) following 14 days of double-blind treatment.
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Part B: The primary efficacy endpoint is the time-normalized area under the FEV1 percent change from pre-dose curve over 24 hours (nAUC0-24) at the 24 hour clinic visit (Visit 7) following 14 days of double-blind treatment.
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Relationship between plasma concentrations of arformoterol and changes in ECG QTc intervals at steady state throughout the dosing interval.
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Part A only: Time-normalized area under the curve for FEV1 percent change from pre-dose over 24 hours (nAUC0-24) for each 24 hour clinic visit.
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14),
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14),
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Part B only: Time-normalized area under curve for the FEV1 percent change from pre-dose over 12 hours (nAUC0-12) for each 24 hour clinic visit.
Time Frame: Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Time-normalized area under the curve for the percent change in FEV1 from pre-dose over 6 hours (nAUC0-6) for the 6 hour clinic visit (Visits 3 and 6).
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Percent change in FEV1 from pre-dose to each post dose time point
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Peak percent change in FEV1 post-dose
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Ipratropium bromide metered-dose inhaler (MDI) use and racemic albuterol MDI use
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Morning and evening peak expiratory flow rate (PEFR)
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Exacerbations of COPD
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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COPD symptom ratings
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Effects of withdrawal from therapy
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Relationship between plasma concentrations of (R,R)-formoterol and selected pharmacodynamic parameters.
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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FEV1 percent change from pre-dose (24-hour trough) following 14 days of double-blind treatment.
Time Frame: Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
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Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 28), Visit 7 (Day 42), Visit 8 (Day 48)
|
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
October 1, 2003
Primary Completion (Actual)
May 1, 2004
Study Completion (Actual)
May 1, 2004
Study Registration Dates
First Submitted
June 2, 2008
First Submitted That Met QC Criteria
June 4, 2008
First Posted (Estimate)
June 5, 2008
Study Record Updates
Last Update Posted (Estimate)
February 22, 2012
Last Update Submitted That Met QC Criteria
February 21, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
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
- Formoterol Fumarate
Other Study ID Numbers
- 091-026
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.