Clinical trial NCT00685841: A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
Keywords: Chronic obstructive pulmonary disease
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 717
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: 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)
timeFrame: Weeks -2, 0, 3, 6, 9, 12
Secondary outcomes:
measure: Time-normalized area under the percent change from visit pre-dose curve for FEV1 over 12 hours (nAUC0-12)
timeFrame: Weeks -2, 0, 3, 6, 9, 12
measure: Peak percent of predicted FEV1
timeFrame: Weeks -2, 0, 3, 6, 9, 12
measure: Time-normalized area under the percent change from study baseline curve for FEV1 over 12 hours (nAUC0-12)
timeFrame: Weeks -2, 0, 3, 6, 9, 12
measure: Time-normalized area under the percent change from study baseline curve for FEV1 over 24 hours (nAUC0-24)
timeFrame: Weeks -2, 0, 3, 6, 9, 12
measure: Timepoint changes in FEV1
timeFrame: Weeks -2, 0, 3, 6, 9, 12
measure: Time to onset of response
timeFrame: Weeks -2, 0, 3, 6, 9, 12
measure: Time to peak change in FEV1
timeFrame: Weeks -2, 0, 3, 6, 9, 12
measure: At-home and in-clinic peak expiratory flow rate (PEFR)
timeFrame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Ipratropium bromide MDI use
timeFrame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Racemic albuterol MDI use
timeFrame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Exacerbations of COPD
timeFrame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: COPD symptom ratings (over 12 weeks of treatment)
timeFrame: Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Relationship between plasma concentrations of (R,R) formoterol and selected pharmacodynamic parameters
timeFrame: Weeks -2, 0, 3, 6, 9, 12
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Birmingham
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state: Alabama
city: Jasper
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state: Alabama
city: Mobile
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state: Alabama
city: Oxford
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city: Little Rock
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state: Arkansas
city: Los Angeles
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state: California
city: Mirage
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state: California
city: Mission Hills
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state: California
city: San Diego
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state: California
city: Santa Ana
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state: California
city: Signal Hill
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state: California
city: Colorado Springs
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state: Colorado
city: Denver
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state: Colorado
city: Wheat Ridge
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state: Colorado
city: Clearwater
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state: Florida
city: DeLand
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state: Florida
city: Miami
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state: Florida
city: Ocala
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city: Pensacola
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state: Florida
city: St. Petersburg
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state: Florida
city: Tampa
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state: Florida
city: Atlanta
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state: Georgia
city: Austell
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state: Georgia
city: Decatur
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state: Georgia
city: Bloomington
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state: Illinois
city: Evansville
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state: Indiana
city: Shawnee Mission
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state: Kansas
city: Minneapolis
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state: Minnesota
city: Charles
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state: Missouri
city: Las Vegas
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state: Nevada
city: Margate
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state: New Jersey
city: South Bound Brook
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state: New Jersey
city: Alburquerque
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state: New Mexico
city: Endwell
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state: New York
city: Ithaca
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state: New York
city: New York
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state: New York
city: Charlotte
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state: North Carolina
city: Raleigh
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state: North Carolina
city: Spartanburg
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state: North Carolina
city: Wilmington
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state: North Carolina
city: Cincinnati
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state: Ohio
city: Tulsa
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state: Oklahoma
city: Medford
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state: Oregon
city: Pittsburg
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state: Pennsylvania
city: Charleston
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state: South Carolina
city: Houston
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state: Texas
city: Irving
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state: Texas
city: San Antonio
country: United States
state: Texas
city: Chesapeake
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
Study officials:
References: