Back to resultsSafety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease, Bronchitis, Emphysema
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Arformoterol tartrate inhalation solution
Arformoterol 25 ųg BID
Formoterol 12 ųg BID
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, chronic bronchitis, emphysema
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Formoterol 12 ųg 2x/day
Arformoterol 15 ųg 2x/day
Arformoterol 25 ųg 2x/day
Arm Description
Outcomes
Primary Outcome Measures
Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations
Percent of participants with the adverse event specified.
SOC = system organ class.
Secondary Outcome Measures
Number of Participants With New 24-Hour Holter Monitoring Alerts
New holter monitoring alerts are defined as those alerts that occurred post-randomization and were not present at baseline.
Number of Participants With Potentially Clinically Significant Glucose Evaluations
Patients with glucose values that met low (<=40 mg/dL) or high (>=175 mg/dL) criteria were considered potentially clinically significant.
Number of Participants With Potentially Clinically Significant Potassium Evaluations
Patients with potassium values that met low (<=3 mEq/L) or high (>=6 mEq/L) criteria were considered potentially clinically significant.
Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts
New Electrocardiogram (ECG) alerts are defined as those alerts that occurred post-treatment and were not present at baseline.
Inspiratory Capacity Changes From Baseline
Mean Change in Inspiratory Capacity values from baseline (baseline assessment obtained at Visit 2, pre-dose). Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis.
6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)
The 6 hour peak change from baseline is the maximum of the post-dose change values through 6 hours at each visit.
Number of Participants With Potentially Clinically Significant Heart Rate
Number of subjects with a heart rate that was lower/higher than a set limit and increased/decreased from set baseline limit in beats per minute (bpm)
Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week
Supplemental medication usage is recorded throughout the study. MDI stands for metered dose inhaler.
Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day
Supplemental medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.
Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week
Rescue medication usage during the study. MDI stands for metered dose inhaler.
Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day
Rescue medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.
Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline
Area under the change from baseline curve from 0 to 6 hours. Time-normalized AUC (0-6 hrs) was derived using the linear trapezoidal method.
Transitional (Relative Change in) Dyspnea Index
The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A Transitional Dyspnea Index score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.
Number of Participants With an Improved Transitional Dyspnea Index
The number of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score compares current health against baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement.
Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)
The 24 hour trough is the FEV1 value obtained 24 hours post first dose. This value is compared to the baseline FEV1 value.
Subject Global Evaluations Change From Baseline
The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1=much better and 7=much worse. Ratings were assessed relative to the subject's initial entry into the study.
Investigator Global Evaluations Change From Baseline
The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse. Ratings were assessed relative to the subject's initial entry into the study.
BODE Index
The BODE index (0=relative health and 10=severe chronic obstructive pulmonary disease) is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the 6-minute walk test. Scores were derived using pre-dose assessments from each visit.
6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes
Mean change from baseline in distance walked (meters)
Mean Change From Baseline in St. George's Respiratory Questionnaire
Scores are expressed as a mean change from baseline of overall impairment (total score). The questionnaire has a scale of 100 which represents worst possible health status to 0 which indicates best possible health status.
Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire
Scores are expressed as the number of participants with >= 4 unit improvement in overall impairment (total score), where 100 represents worst possible health status and 0 indicates best possible health status.
Modified Medical Research Council Dyspnea Questionaire
Scores range from 0 to 4, with a score of 4 indicating that a subject is too breathless to leave the house or becomes breathless when dressing or undressing. The highest numbered question to which the subject answered 'Yes' is the Dyspnea Scale Score.
Percent (%) of Participants With an Improved Transitional Dyspnea Index
The percentage of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score is the sum of the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement.
Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire
Percent of participants with a >=4 unit improvement in the overall impairment (total score) of the St. George's Respiratory Questionaire. This questionaire uses a 100 - 0 scale, where 100 represents the worst possible health status and 0 indicates the best possible health status.
Mean Values for the 6-Minute Walk Test: Distance Walked in Meters
This test measures the participants' level of fitness. It is a measure of the distance the participant can walk in 6 minutes.
Mean Values for Investigator Global Evaluations
The investigator global evaluation is reported by the study investigator. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse.
Mean Values for St. George's Respiratory Questionnaire
A questionnaire to assess respiratory health. Scores are expressed as a percentage of overall impairment (total score), where 100 represents the worst possible health status and 0 indicates best possible health status.
Mean Values for Subject Global Evaluations
The subject global evaluation is reported by study subjects/participants. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse.
Mean Values for Inspiratory Capacity
Inspiratory capacity is the maximum volume that can be inhaled.
Mean Values for Forced Expiratory Volume in One Second (FEV1)
Forced Expiratory Volume in one second
Full Information
NCT ID
NCT00250679
First Posted
November 4, 2005
Last Updated
May 29, 2012
Sponsor
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00250679
Brief Title
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
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Bronchitis, Emphysema
Keywords
COPD, chronic bronchitis, emphysema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
443 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Formoterol 12 ųg 2x/day
Arm Type
Active Comparator
Arm Title
Arformoterol 15 ųg 2x/day
Arm Type
Experimental
Arm Title
Arformoterol 25 ųg 2x/day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Arformoterol tartrate inhalation solution
Other Intervention Name(s)
Brovana®
Intervention Description
Arformoterol 15 ųg BID by nebulization
Intervention Type
Drug
Intervention Name(s)
Arformoterol 25 ųg BID
Other Intervention Name(s)
Brovana, R,R formoterol
Intervention Description
Arformoterol 25 ųg BID by nebulization
Intervention Type
Drug
Intervention Name(s)
Formoterol 12 ųg BID
Other Intervention Name(s)
Foradil, R,S-formoterol
Intervention Description
Formoterol fumarate 12 ųg BID via aerolizer/DPI
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo nebule or placebo aerolizer
Primary Outcome Measure Information:
Title
Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations
Description
Percent of participants with the adverse event specified.
SOC = system organ class.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Number of Participants With New 24-Hour Holter Monitoring Alerts
Description
New holter monitoring alerts are defined as those alerts that occurred post-randomization and were not present at baseline.
Time Frame
Visit 6 (week 27)
Title
Number of Participants With Potentially Clinically Significant Glucose Evaluations
Description
Patients with glucose values that met low (<=40 mg/dL) or high (>=175 mg/dL) criteria were considered potentially clinically significant.
Time Frame
visit 6 (week 27)
Title
Number of Participants With Potentially Clinically Significant Potassium Evaluations
Description
Patients with potassium values that met low (<=3 mEq/L) or high (>=6 mEq/L) criteria were considered potentially clinically significant.
Time Frame
visit 6 (week 27)
Title
Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts
Description
New Electrocardiogram (ECG) alerts are defined as those alerts that occurred post-treatment and were not present at baseline.
Time Frame
visit 6 (week 27)
Title
Inspiratory Capacity Changes From Baseline
Description
Mean Change in Inspiratory Capacity values from baseline (baseline assessment obtained at Visit 2, pre-dose). Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis.
Time Frame
weeks 0,3,13,26
Title
6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)
Description
The 6 hour peak change from baseline is the maximum of the post-dose change values through 6 hours at each visit.
Time Frame
weeks 0,3,13,26
Title
Number of Participants With Potentially Clinically Significant Heart Rate
Description
Number of subjects with a heart rate that was lower/higher than a set limit and increased/decreased from set baseline limit in beats per minute (bpm)
Time Frame
visit 6 (week 27)
Title
Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week
Description
Supplemental medication usage is recorded throughout the study. MDI stands for metered dose inhaler.
Time Frame
Screening (day-14 to 0) and Treatment (week 0 - 26)
Title
Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day
Description
Supplemental medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.
Time Frame
Screening (day-14 to 0) and Treatment (week 0 - 26)
Title
Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week
Description
Rescue medication usage during the study. MDI stands for metered dose inhaler.
Time Frame
Screening (day-14 to 0) and Treatment (week 0 - 26)
Title
Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day
Description
Rescue medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.
Time Frame
Screening (day-14 to 0) and Treatment (week 0 - 26)
Title
Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline
Description
Area under the change from baseline curve from 0 to 6 hours. Time-normalized AUC (0-6 hrs) was derived using the linear trapezoidal method.
Time Frame
weeks 0,3,13,26
Title
Transitional (Relative Change in) Dyspnea Index
Description
The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A Transitional Dyspnea Index score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.
Time Frame
weeks 13, 26
Title
Number of Participants With an Improved Transitional Dyspnea Index
Description
The number of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score compares current health against baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement.
Time Frame
weeks 13, 26
Title
Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)
Description
The 24 hour trough is the FEV1 value obtained 24 hours post first dose. This value is compared to the baseline FEV1 value.
Time Frame
weeks 0,3,13,26
Title
Subject Global Evaluations Change From Baseline
Description
The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1=much better and 7=much worse. Ratings were assessed relative to the subject's initial entry into the study.
Time Frame
weeks 13, 26
Title
Investigator Global Evaluations Change From Baseline
Description
The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse. Ratings were assessed relative to the subject's initial entry into the study.
Time Frame
weeks 13, 26
Title
BODE Index
Description
The BODE index (0=relative health and 10=severe chronic obstructive pulmonary disease) is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the 6-minute walk test. Scores were derived using pre-dose assessments from each visit.
Time Frame
Baseline (visit 2), weeks 13, 26
Title
6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes
Description
Mean change from baseline in distance walked (meters)
Time Frame
Post-Dose weeks 0, 13, 26
Title
Mean Change From Baseline in St. George's Respiratory Questionnaire
Description
Scores are expressed as a mean change from baseline of overall impairment (total score). The questionnaire has a scale of 100 which represents worst possible health status to 0 which indicates best possible health status.
Time Frame
weeks 13, 26
Title
Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire
Description
Scores are expressed as the number of participants with >= 4 unit improvement in overall impairment (total score), where 100 represents worst possible health status and 0 indicates best possible health status.
Time Frame
Visit 4 (week 13) , Visit 5 (week 26)
Title
Modified Medical Research Council Dyspnea Questionaire
Description
Scores range from 0 to 4, with a score of 4 indicating that a subject is too breathless to leave the house or becomes breathless when dressing or undressing. The highest numbered question to which the subject answered 'Yes' is the Dyspnea Scale Score.
Time Frame
Baseline (visit 2), weeks 13, 26
Title
Percent (%) of Participants With an Improved Transitional Dyspnea Index
Description
The percentage of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score is the sum of the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement.
Time Frame
visits 4 (week 13), visit 5 (week 26)
Title
Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire
Description
Percent of participants with a >=4 unit improvement in the overall impairment (total score) of the St. George's Respiratory Questionaire. This questionaire uses a 100 - 0 scale, where 100 represents the worst possible health status and 0 indicates the best possible health status.
Time Frame
visit 4 (week 13), visit 5 (week 26)
Title
Mean Values for the 6-Minute Walk Test: Distance Walked in Meters
Description
This test measures the participants' level of fitness. It is a measure of the distance the participant can walk in 6 minutes.
Time Frame
Baseline (Visit 2), week 13, week 26
Title
Mean Values for Investigator Global Evaluations
Description
The investigator global evaluation is reported by the study investigator. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse.
Time Frame
Baseline (Visit 2), Weeks 13, 26
Title
Mean Values for St. George's Respiratory Questionnaire
Description
A questionnaire to assess respiratory health. Scores are expressed as a percentage of overall impairment (total score), where 100 represents the worst possible health status and 0 indicates best possible health status.
Time Frame
Baseline (Visit 2), weeks 13, 26
Title
Mean Values for Subject Global Evaluations
Description
The subject global evaluation is reported by study subjects/participants. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse.
Time Frame
Baseline (Visit 2), weeks 13, 26
Title
Mean Values for Inspiratory Capacity
Description
Inspiratory capacity is the maximum volume that can be inhaled.
Time Frame
Baseline (Visit 2), Weeks 3, 13, 26
Title
Mean Values for Forced Expiratory Volume in One Second (FEV1)
Description
Forced Expiratory Volume in one second
Time Frame
Baseline (Visit 2), weeks 3, 13, 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sepracor Medical Director
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Jasper
State/Province
Alabama
Country
United States
City
Mobile
State/Province
Alabama
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Carmichael
State/Province
California
Country
United States
City
Fullerton
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Paramount
State/Province
California
Country
United States
City
Rancho Mirage
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Walnut Creek
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Hartford
State/Province
Connecticut
Country
United States
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
City
Brandon
State/Province
Florida
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
City
Panama City
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Normal
State/Province
Illinois
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Topeka
State/Province
Kansas
Country
United States
City
East Slidell
State/Province
Louisiana
Country
United States
City
Lafayette
State/Province
Louisiana
Country
United States
City
Metairie
State/Province
Louisiana
Country
United States
City
Sunset
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Chester
State/Province
Maryland
Country
United States
City
Wheaton
State/Province
Maryland
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
St. Charles
State/Province
Missouri
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Lake Oswego
State/Province
Oregon
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Swarthmore
State/Province
Pennsylvania
Country
United States
City
East Providence
State/Province
Rhode Island
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Simpsonville
State/Province
South Carolina
Country
United States
City
Spartanburg
State/Province
South Carolina
Country
United States
City
Union
State/Province
South Carolina
ZIP/Postal Code
29379
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Katy
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Danville
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Tacoma
State/Province
Washington
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20214460
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.
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Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
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