Clinical trial NCT00250679: Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Bronchitis
Emphysema
Keywords: COPD
chronic bronchitis
emphysema
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2005-11-08
Enrollment: 443
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: 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).

Detailed description: This is a double-blind, double-dummy, multicenter, randomized, active-controlled, parallel group, outpatient, safety study to evaluate the long term safety of arformoterol in the treatment of subjects with COPD. Study participation will be over approximately 6 months. 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: Key Inclusion Criteria:

* 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.

Key Exclusion criteria:

* 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)

Primary outcomes:
measure: Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations
timeFrame: Six months
Secondary outcomes:
measure: Number of Participants With New 24-Hour Holter Monitoring Alerts
timeFrame: Visit 6 (week 27)
measure: Number of Participants With Potentially Clinically Significant Glucose Evaluations
timeFrame: visit 6 (week 27)
measure: Number of Participants With Potentially Clinically Significant Potassium Evaluations
timeFrame: visit 6 (week 27)
measure: Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts
timeFrame: visit 6 (week 27)
measure: Inspiratory Capacity Changes From Baseline
timeFrame: weeks 0,3,13,26
measure: 6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)
timeFrame: weeks 0,3,13,26
measure: Number of Participants With Potentially Clinically Significant Heart Rate
timeFrame: visit 6 (week 27)
measure: Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week
timeFrame: Screening (day-14 to 0) and Treatment (week 0 - 26)
measure: Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day
timeFrame: Screening (day-14 to 0) and Treatment (week 0 - 26)
measure: Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week
timeFrame: Screening (day-14 to 0) and Treatment (week 0 - 26)
measure: Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day
timeFrame: Screening (day-14 to 0) and Treatment (week 0 - 26)
measure: Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline
timeFrame: weeks 0,3,13,26
measure: Transitional (Relative Change in) Dyspnea Index
timeFrame: weeks 13, 26
measure: Number of Participants With an Improved Transitional Dyspnea Index
timeFrame: weeks 13, 26
measure: Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)
timeFrame: weeks 0,3,13,26
measure: Subject Global Evaluations Change From Baseline
timeFrame: weeks 13, 26
measure: Investigator Global Evaluations Change From Baseline
timeFrame: weeks 13, 26
measure: BODE Index
timeFrame: Baseline (visit 2), weeks 13, 26
measure: 6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes
timeFrame: Post-Dose weeks 0, 13, 26
measure: Mean Change From Baseline in St. George's Respiratory Questionnaire
timeFrame: weeks 13, 26
measure: Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire
timeFrame: Visit 4 (week 13) , Visit 5 (week 26)
measure: Modified Medical Research Council Dyspnea Questionaire
timeFrame: Baseline (visit 2), weeks 13, 26
measure: Percent (%) of Participants With an Improved Transitional Dyspnea Index
timeFrame: visits 4 (week 13), visit 5 (week 26)
measure: Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire
timeFrame: visit 4 (week 13), visit 5 (week 26)
measure: Mean Values for the 6-Minute Walk Test: Distance Walked in Meters
timeFrame: Baseline (Visit 2), week 13, week 26
measure: Mean Values for Investigator Global Evaluations
timeFrame: Baseline (Visit 2), Weeks 13, 26
measure: Mean Values for St. George's Respiratory Questionnaire
timeFrame: Baseline (Visit 2), weeks 13, 26
measure: Mean Values for Subject Global Evaluations
timeFrame: Baseline (Visit 2), weeks 13, 26
measure: Mean Values for Inspiratory Capacity
timeFrame: Baseline (Visit 2), Weeks 3, 13, 26
measure: Mean Values for Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline (Visit 2), weeks 3, 13, 26
Other outcomes:
Locations:
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country: United States
state: Alabama
city: Jasper
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state: Alabama
city: Mobile
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state: Alabama
city: Little Rock
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state: Arkansas
city: Carmichael
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state: California
city: Fullerton
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state: California
city: Long Beach
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state: California
city: Paramount
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state: California
city: Rancho Mirage
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state: California
city: San Diego
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state: California
city: Walnut Creek
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state: California
city: Denver
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state: Colorado
city: Hartford
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state: Connecticut
city: Bay Pines
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state: Florida
city: Brandon
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state: Florida
city: Gainesville
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state: Florida
city: Panama City
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state: Florida
city: Tampa
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state: Florida
city: Atlanta
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state: Georgia
city: Marietta
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state: Georgia
city: Normal
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state: Illinois
city: Evansville
country: United States
state: Indiana
city: Topeka
country: United States
state: Kansas
city: East Slidell
country: United States
state: Louisiana
city: Lafayette
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: Sunset
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Chester
country: United States
state: Maryland
city: Wheaton
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: St. Charles
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Lake Oswego
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Swarthmore
country: United States
state: Pennsylvania
city: East Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Union
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Danville
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Sepracor Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.