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To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
arformoterol
Salmeterol
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: In order to qualify for participation, subjects must meet the following criteria: Must give written informed consent prior to participation. Women of childbearing potential must also sign the Women of Childbearing Potential Addendum. Must be willing to comply with study procedures and visit schedule Male or female >35 years of age Female subjects <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: (1) documented surgically sterile, OR (2) postmenopausal Have a primary diagnosis of COPD, which may include components of chronic bronchitis and/or emphysema. Diagnosis can be made during the screening process. Have a minimum smoking history of 15 pack-years (pack-years = the number of cigarette packs per day times the number of years) Medical Research Council (MRC) Dyspnea Scale Score >2 Have a baseline FEV1 <65% of predicted normal value and >0.70 L documented prior to randomization Have an FEV1/FVC ratio <70% documented prior to randomization. Have a chest x-ray that is consistent with the diagnosis of COPD and taken <3 months prior to Visit 1. If there is no chest x-ray taken 3 months prior to Visit 1, a chest x-ray will be performed prior to Visit 2. Be able to complete all study questionnaires and logs reliably EXCLUSION CRITERIA: In order to qualify for participation, subjects must not meet any of the following criteria: Currently using disallowed medications or will be unable to complete the medication washout periods Female subject who is pregnant or lactating Have participated in an investigational drug study within 30 days prior to Visit 1 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 Visit 1 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 blood eosinophil count >5% Subject with clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol History of cancer except non-melanomatous skin cancer History of lung resection of more than one full lobe Subject who requires continuous supplemental oxygen therapy. The use of supplemental oxygen, not to exceed 2 L/minute, at nighttime only and/or only during exercise is allowed. Have had a change in dose or type of any medications for COPD within 14 days prior to the screening visit Have a known sensitivity to (R,R)-formoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations Have clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug Have a history of substance abuse or drug abuse within 12 months of Visit 1 or with a positive urine drug screen at the screening visit Subject with clinically significant abnormal laboratory values Subject with clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete the study Subject using any prescription drug for which concomitant beta-agonist administration is contraindicated

Sites / Locations

  • Pinnacle Research Group
  • Princeton Pulmonary Group, PC
  • Pulmonary & Sleep Associates of Jasper, PC
  • Pulmonary Associates of Mobile, P.C.
  • Arizona Clinical Research Center, Inc.
  • Northern California Research Corp.
  • SARC Research Center
  • Irvine Center for Clinical Research
  • Scripps Clinic - Chest and Critical Care
  • Torrance Clinical Research
  • Facey Medical Center - Radiant Research
  • Office of Delmer Henninger, MD
  • Advanced Clinical Research Institute
  • Center for Clinical Trials, LLC
  • Advances in Medicine
  • Inland Clinical Research, Inc.
  • Institute of Healthcare Assessment, Inc.
  • Wetlin Research Associates, Inc.
  • San Jose Clinical Research, Inc.
  • West Coast Clinical Trials
  • Allergy & Asthma Medical Group of Diablo Valley, Inc.
  • Northern Colorado Pulmonary Consultants, PC
  • Clinical Research of West Florida, Inc.
  • University Clinical Research, DeLand
  • nTouch Research
  • nTouch Research
  • USF Asthma, Allergy and Immunology
  • AHS Medical Research, Inc.
  • New Horizon Health Research
  • Protocare Trial, Inc.
  • nTouch Research
  • Marietta Pulmonary Medicine
  • North Point Pulmonary Associates
  • Pulmonary Consultants
  • University of Chicago - Department of Medicine
  • Sneeze, Wheeze and Itch, LLC
  • Medisphere Medical Research Center, LLC
  • South Bend Clinic
  • Heart of America Research Institute
  • Bendel Medical Associates
  • New Orleans Center for Clinical Research
  • North Shore Research Associates
  • Office of Paul A. Shapero, MD, PA
  • Primary Care Cardiology Research, Inc.
  • Center for Clinical Research
  • ClinSite, Inc.
  • Minnesota Lung Center
  • MedEx HealthCare Research, Inc.
  • Midwest Chest Consultants, PC
  • C.A.R.E Clinical Research
  • Office of Keith Popovich, MD
  • Montana Medical Research, LLC
  • Clinical Research Center of Nevada
  • Advanced Biomedical Research of America
  • Atlantic Research Associates, Inc.
  • UrgentMed Family Practice Medical
  • Lovelace Scientific Resources - NM
  • Endwell Family Physicians
  • Asthma & Allergy Associates, PC
  • N.Y. Pulmonary Associates
  • Ridgewood Medical Group
  • Charlotte Lung and Health Center
  • North Carolina Clinical Research
  • New Hanover Medical Research
  • Odyssey Research Services
  • Community Research Management Associates, Inc.
  • New Horizons Clinical Research, Inc.
  • COR Clinical Research LLC
  • Healthcare Research Consultants
  • Clinical Research Institute of Southern Oregon, PC
  • Medford Medical Clinic, LLP
  • Allergy Associates Research Center
  • Northeast Clinical Research Center, Inc.
  • University of Pittsburgh
  • Consortium Clinical Research, Ltd.
  • Safe Harbor Clinical Research
  • Spartanburg Pharmaceutical Research
  • Volunteer Research Group
  • Ben Taub General Hospital
  • S.W. Asthma Institute
  • Breath of Life Research Institute
  • Wellmed at Northern Hills
  • Medsource, Inc.
  • Pulmonary Associates of Fredericksburg, Inc.
  • Pulmonary Associates of Richmond, Inc.
  • Commonwealth Clinical Research
  • Virginia Adult & Pediatric Allergy & Asthma, PC Research Office
  • Pulmonary Research Partners, Inc.
  • Pulmonary Consultants, PLLC
  • Morgantown Pulmonary Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Arformoterol tartrate 50 mcg QD

Salmeterol 42 mcg BID

Outcomes

Primary Outcome Measures

Overall occurrence of adverse events

Secondary Outcome Measures

Laboratory parameters
ECG parameters
24-hour holter monitoring parameters
Vital signs
Plasma arformoterol concentrations
Physical examination findings

Full Information

First Posted
July 8, 2003
Last Updated
February 21, 2012
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00064415
Brief Title
To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD
Official Title
A Multicenter, Open-Label, Randomized, Active-Controlled, Parallel Group Chronic Safety Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (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
The purpose of this study is to determine the long-term safety of arformoterol over a period of 12 months in subjects with COPD
Detailed Description
This was a multicenter, open-label, randomized, active controlled, parallel group chronic safety study of arformoterol 50 mcg once daily over a period of 12 months in subjects with COPD. 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, Chronic Bronchitis, Emphysema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
799 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Arformoterol tartrate 50 mcg QD
Arm Title
2
Arm Type
Active Comparator
Arm Description
Salmeterol 42 mcg BID
Intervention Type
Drug
Intervention Name(s)
arformoterol
Other Intervention Name(s)
Brovana Inhalation Solution, (R,R)-Formoterol
Intervention Description
Arformoterol inhalation solution, 50 mcg QD
Intervention Type
Drug
Intervention Name(s)
Salmeterol
Other Intervention Name(s)
Serevent MDI, racemic formoterol
Intervention Description
Salmeterol MDI, 42 mcg BID
Primary Outcome Measure Information:
Title
Overall occurrence of adverse events
Time Frame
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Secondary Outcome Measure Information:
Title
Laboratory parameters
Time Frame
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Title
ECG parameters
Time Frame
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Title
24-hour holter monitoring parameters
Time Frame
Weeks -1, 0, 13, 26, 39, 52
Title
Vital signs
Time Frame
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Title
Plasma arformoterol concentrations
Time Frame
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Title
Physical examination findings
Time Frame
Weeks -1, 53

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: In order to qualify for participation, subjects must meet the following criteria: Must give written informed consent prior to participation. Women of childbearing potential must also sign the Women of Childbearing Potential Addendum. Must be willing to comply with study procedures and visit schedule Male or female >35 years of age Female subjects <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: (1) documented surgically sterile, OR (2) postmenopausal Have a primary diagnosis of COPD, which may include components of chronic bronchitis and/or emphysema. Diagnosis can be made during the screening process. Have a minimum smoking history of 15 pack-years (pack-years = the number of cigarette packs per day times the number of years) Medical Research Council (MRC) Dyspnea Scale Score >2 Have a baseline FEV1 <65% of predicted normal value and >0.70 L documented prior to randomization Have an FEV1/FVC ratio <70% documented prior to randomization. Have a chest x-ray that is consistent with the diagnosis of COPD and taken <3 months prior to Visit 1. If there is no chest x-ray taken 3 months prior to Visit 1, a chest x-ray will be performed prior to Visit 2. Be able to complete all study questionnaires and logs reliably EXCLUSION CRITERIA: In order to qualify for participation, subjects must not meet any of the following criteria: Currently using disallowed medications or will be unable to complete the medication washout periods Female subject who is pregnant or lactating Have participated in an investigational drug study within 30 days prior to Visit 1 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 Visit 1 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 blood eosinophil count >5% Subject with clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol History of cancer except non-melanomatous skin cancer History of lung resection of more than one full lobe Subject who requires continuous supplemental oxygen therapy. The use of supplemental oxygen, not to exceed 2 L/minute, at nighttime only and/or only during exercise is allowed. Have had a change in dose or type of any medications for COPD within 14 days prior to the screening visit Have a known sensitivity to (R,R)-formoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations Have clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug Have a history of substance abuse or drug abuse within 12 months of Visit 1 or with a positive urine drug screen at the screening visit Subject with clinically significant abnormal laboratory values Subject with clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete the study Subject using any prescription drug for which concomitant beta-agonist administration is contraindicated
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Princeton Pulmonary Group, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Pulmonary & Sleep Associates of Jasper, PC
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Pulmonary Associates of Mobile, P.C.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arizona Clinical Research Center, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Northern California Research Corp.
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
SARC Research Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Irvine Center for Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Scripps Clinic - Chest and Critical Care
City
LaJolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Torrance Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Facey Medical Center - Radiant Research
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Office of Delmer Henninger, MD
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Orange
State/Province
California
Country
United States
Facility Name
Center for Clinical Trials, LLC
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Advances in Medicine
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Inland Clinical Research, Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Institute of Healthcare Assessment, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Wetlin Research Associates, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
San Jose Clinical Research, Inc.
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
West Coast Clinical Trials
City
Signal Hill
State/Province
California
ZIP/Postal Code
90755
Country
United States
Facility Name
Allergy & Asthma Medical Group of Diablo Valley, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Northern Colorado Pulmonary Consultants, PC
City
Ft. Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
University Clinical Research, DeLand
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
nTouch Research
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
nTouch Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
USF Asthma, Allergy and Immunology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
AHS Medical Research, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
New Horizon Health Research
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Protocare Trial, Inc.
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
nTouch Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Marietta Pulmonary Medicine
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
North Point Pulmonary Associates
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Pulmonary Consultants
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
University of Chicago - Department of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Sneeze, Wheeze and Itch, LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Medisphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Heart of America Research Institute
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66216
Country
United States
Facility Name
Bendel Medical Associates
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
North Shore Research Associates
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70461
Country
United States
Facility Name
Office of Paul A. Shapero, MD, PA
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Primary Care Cardiology Research, Inc.
City
Ayer
State/Province
Massachusetts
ZIP/Postal Code
01432
Country
United States
Facility Name
Center for Clinical Research
City
Taunton
State/Province
Massachusetts
ZIP/Postal Code
02780
Country
United States
Facility Name
ClinSite, Inc.
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Minnesota Lung Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
MedEx HealthCare Research, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Midwest Chest Consultants, PC
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301-2847
Country
United States
Facility Name
C.A.R.E Clinical Research
City
St. Louis,
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Office of Keith Popovich, MD
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Montana Medical Research, LLC
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Atlantic Research Associates, Inc.
City
Margate City
State/Province
New Jersey
ZIP/Postal Code
08402
Country
United States
Facility Name
UrgentMed Family Practice Medical
City
South Bound Brook
State/Province
New Jersey
ZIP/Postal Code
08880
Country
United States
Facility Name
Lovelace Scientific Resources - NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Endwell Family Physicians
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Asthma & Allergy Associates, PC
City
Ithaca
State/Province
New York
ZIP/Postal Code
14850
Country
United States
Facility Name
N.Y. Pulmonary Associates
City
New York City
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Ridgewood Medical Group
City
Rochester
State/Province
New York
ZIP/Postal Code
14626
Country
United States
Facility Name
Charlotte Lung and Health Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
New Hanover Medical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28412
Country
United States
Facility Name
Odyssey Research Services
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Community Research Management Associates, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
New Horizons Clinical Research, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45241
Country
United States
Facility Name
COR Clinical Research LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Healthcare Research Consultants
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, PC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Medford Medical Clinic, LLP
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Allergy Associates Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Northeast Clinical Research Center, Inc.
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Consortium Clinical Research, Ltd.
City
Ridley Park
State/Province
Pennsylvania
ZIP/Postal Code
19078
Country
United States
Facility Name
Safe Harbor Clinical Research
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Spartanburg Pharmaceutical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
S.W. Asthma Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Breath of Life Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Wellmed at Northern Hills
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Medsource, Inc.
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Pulmonary Associates of Fredericksburg, Inc.
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
Facility Name
Pulmonary Associates of Richmond, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Commonwealth Clinical Research
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Virginia Adult & Pediatric Allergy & Asthma, PC Research Office
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Pulmonary Research Partners, Inc.
City
South Boston
State/Province
Virginia
ZIP/Postal Code
24592
Country
United States
Facility Name
Pulmonary Consultants, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Morgantown Pulmonary Associates
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States

12. IPD Sharing Statement

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To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD

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