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Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of 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 tartrate inhalation solution
arformoterol tartrate inhalation solution
arformoterol tartrate inhalation solution
Salmeterol
Placebo
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: Be willing to comply with study procedures and visit schedule Are at least 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: documented surgically sterile, OR postmenopausal. Have a primary diagnosis of COPD. 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). Have a chest x-ray that is consistent with the diagnosis of COPD and taken <3 months prior to study start Able to complete all study questionnaires and logs reliably Exclusion Criteria: Female subject who is pregnant or lactating Have 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 Are scheduled for in-patient hospitalization, including elective surgery during the trial Have life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days History of asthma or any chronic respiratory disease other than COPD (chronic bronchitis and/or emphysema) Have clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol Have a history of cancer except non-melanomatous skin cancer Have a history of lung resection of more than one full lobe Requires continuous supplemental oxygen therapy. Has 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 arformoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations Have a history of substance abuse or drug abuse within 12 months, or with a positive urine drug screen Are using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers)

Sites / Locations

  • Pulmonary & Sleep Associates of Jasper, PC
  • Pulmonary Associates, PA
  • Arizona Clinical Research Center, Inc.
  • Northern California Research Corp.
  • SARC Research Center
  • California Research Medical Group, Inc.
  • Radiant Research-Irvine
  • West Coast Clinical Trials
  • Center for Clinical Trials, LLC
  • Advances in Medicine
  • Institute of Healthcare Assessment, Inc.
  • San Jose Clinical Research
  • Allergy & Asthma Medical Group of Diablo Valley, Inc.
  • Colorado Pulmonary Associates
  • Northern Colorado Pulmonary Consultants, PC
  • Physicians Research Center, Inc.
  • Washington Hospital Center
  • Clinical Research of West Florida, Inc.
  • University Clinical Research, DeLand
  • Mt. Sinai Medical Center
  • Clinical Pharmacology Services
  • Protocare Trial, Inc.
  • Marietta Pulmonary Medicine
  • Office of Bradley Sakran, MD, PC
  • South Bend Clinic
  • Family Allergy & Asthma Research Institute
  • Cumberland Lung and Sleep Specialists
  • Bendel Medical Associates/Research
  • Best Clinical Trials, LLC
  • New Orleans Center for Clinical Research
  • New Orleans Center for Clinical Research
  • North Shore Research Associates
  • Sunset Medical Research
  • University of Maryland-Airways Research Center
  • Institute of Asthma and Allergy
  • Pro-Medica Clinical Research Center
  • ClinSite, Inc.
  • MedEx HealthCare Research, Inc.
  • Midwest Chest Consultants, PC
  • C.A.R.E Clinical Research
  • Office of Keith Popovich, MD
  • Montana Medical Research, LLC
  • VA Medical Center
  • Advanced Biomedical Research of America
  • Pulmonary Medicine
  • Charlotte Lung and Health Center
  • Carolina Pharmaceutical Research, Inc.
  • New Hanover Medical Research
  • New Horizons Clinical Research, Inc.
  • COR Clinical Research LLC
  • Allergy Associates Research Center
  • Northeast Clinical Research Centers, Inc.
  • Keystone Clinical Solutions
  • Philadelphia Health Associates - Adult Medicine
  • Consortium Clinical Research, Ltd.
  • Safe Harbor Clinical Research
  • Spartanburg Pharmaceutical Research
  • Volunteer Research Group
  • Breath of Life Research Institute
  • Central Texas Health Research
  • Sylvana Research Associates
  • Pulmonary Associates of Fredericksburg, Inc.
  • Pulmonary Associates of Richmond, Inc.
  • Bellingham Asthma, Allergy & Immunology Clinic
  • University of Wisconsin-Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

5

Arm Description

Arformoterol 50 mcg QD and placebo MDI

Arformoterol 25 mcg BID and Placebo MDI

Arformoterol 15 mcg BID and placebo MDI

Salmeterol MDI 42 mcg BID and placebo inhalation solution

Placebo MDI and placebo inhalation solution

Outcomes

Primary Outcome Measures

percent change in trough FEV1 from study baseline to the end of the dosing interval (12 hours post-second dose for the BID treatment arms and 24 hours postdose for the QD treatment arm) over the double-blind period.

Secondary Outcome Measures

time-normalized area under the percent change from visit predose curve for FEV1 over 12 hours (nAUC0-12-P)
Peak percent of predicted FEV1
time-normalized area under the percent change in FEV1 from study baseline over 12 hours (nAUC0-12-B)
time-normalized area under the percent change from visit predose curve for FEV1 over 24 hours (nAUC0-24-P)
time-normalized area under the percent change in FEV1 from study baseline curve over 24 hours (nAUC0-24-B)
peak percent change in FEV1 from visit predose and study baseline
time point changes in FEV1; time to onset of response
time to peak change in FEV1
at-home and in-clinic peak expiratory flow rate (PEFR)
relationship between the plasma concentration values and selected pharmacodynamic parameters
Supplemental ipratropium bromide MDI and racemic albuterol MDI use
COPD exacerbations and COPD symptom ratings
St. George's Hospital Respiratory Questionnaire
Investigator and Subject Global Evaluations
Baseline and Transitional Dyspnea Index
distance walked in six minutes

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
NCT00064402
Brief Title
Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With 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

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 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 assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD
Detailed Description
This was a double-blind, double-dummy, randomized, placebo- and active-controlled, multicenter, parallel-group study of adult subjects with COPD. The study was double blinded through the use of both unit dose vial (UDV) and metered-dose inhaler (MDI) placebos, as appropriate. The primary efficacy analysis utilized the placebo control. Secondary analyses of the primary efficacy endpoint utilized the active control, and included comparisons between the placebo and active control. 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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
741 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Arformoterol 50 mcg QD and placebo MDI
Arm Title
2
Arm Type
Experimental
Arm Description
Arformoterol 25 mcg BID and Placebo MDI
Arm Title
3
Arm Type
Experimental
Arm Description
Arformoterol 15 mcg BID and placebo MDI
Arm Title
4
Arm Type
Active Comparator
Arm Description
Salmeterol MDI 42 mcg BID and placebo inhalation solution
Arm Title
5
Arm Type
Placebo Comparator
Arm Description
Placebo MDI and placebo inhalation solution
Intervention Type
Drug
Intervention Name(s)
arformoterol tartrate inhalation solution
Other Intervention Name(s)
(R,R)-formoterol
Intervention Description
arformoterol 50 mcg QD
Intervention Type
Drug
Intervention Name(s)
arformoterol tartrate inhalation solution
Other Intervention Name(s)
(R,R)-formoterol
Intervention Description
arformoterol 25 mcg BID
Intervention Type
Drug
Intervention Name(s)
arformoterol tartrate inhalation solution
Other Intervention Name(s)
(R,R)-formoterol, Brovana
Intervention Description
arformoterol 15 mcg BID
Intervention Type
Drug
Intervention Name(s)
Salmeterol
Other Intervention Name(s)
Serevent MDI
Intervention Description
Salmeterol MDI 42 mcg BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo BID
Primary Outcome Measure Information:
Title
percent change in trough FEV1 from study baseline to the end of the dosing interval (12 hours post-second dose for the BID treatment arms and 24 hours postdose for the QD treatment arm) over the double-blind period.
Time Frame
Weeks -2, 0, 3, 6, 9, 12
Secondary Outcome Measure Information:
Title
time-normalized area under the percent change from visit predose curve for FEV1 over 12 hours (nAUC0-12-P)
Time Frame
Weeks -2, 0, 3, 6, 9, 12
Title
Peak percent of predicted FEV1
Time Frame
Weeks -2, 0, 3, 6, 9, 12
Title
time-normalized area under the percent change in FEV1 from study baseline over 12 hours (nAUC0-12-B)
Time Frame
Weeks -2, 0, 3, 6, 9, 12
Title
time-normalized area under the percent change from visit predose curve for FEV1 over 24 hours (nAUC0-24-P)
Time Frame
Weeks -2, 0, 3, 6, 9, 12
Title
time-normalized area under the percent change in FEV1 from study baseline curve over 24 hours (nAUC0-24-B)
Time Frame
Weeks -2, 0, 3, 6, 9, 12
Title
peak percent change in FEV1 from visit predose and study baseline
Time Frame
Weeks -2, 0, 3, 6, 9, 12
Title
time point changes in FEV1; time to onset of response
Time Frame
Weeks -2, 0, 3, 6, 9, 12
Title
time to peak change in FEV1
Time Frame
Weeks -2, 0, 3, 6, 9, 12
Title
at-home and in-clinic peak expiratory flow rate (PEFR)
Time Frame
Weeks -2, 0, 3, 6, 9, 12
Title
relationship between the plasma concentration values and selected pharmacodynamic parameters
Time Frame
Weeks -2, 0, 3, 6, 9, 12, 13
Title
Supplemental ipratropium bromide MDI and racemic albuterol MDI use
Time Frame
Weeks 0-13
Title
COPD exacerbations and COPD symptom ratings
Time Frame
Weeks 0-13
Title
St. George's Hospital Respiratory Questionnaire
Time Frame
Weeks 0, 6, 13
Title
Investigator and Subject Global Evaluations
Time Frame
Weeks -2, 12, 13
Title
Baseline and Transitional Dyspnea Index
Time Frame
Weeks -2, 6, 12
Title
distance walked in six minutes
Time Frame
Weeks -2, 3, 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be willing to comply with study procedures and visit schedule Are at least 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: documented surgically sterile, OR postmenopausal. Have a primary diagnosis of COPD. 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). Have a chest x-ray that is consistent with the diagnosis of COPD and taken <3 months prior to study start Able to complete all study questionnaires and logs reliably Exclusion Criteria: Female subject who is pregnant or lactating Have 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 Are scheduled for in-patient hospitalization, including elective surgery during the trial Have life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days History of asthma or any chronic respiratory disease other than COPD (chronic bronchitis and/or emphysema) Have clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol Have a history of cancer except non-melanomatous skin cancer Have a history of lung resection of more than one full lobe Requires continuous supplemental oxygen therapy. Has 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 arformoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations Have a history of substance abuse or drug abuse within 12 months, or with a positive urine drug screen Are using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers)
Facility Information:
Facility Name
Pulmonary & Sleep Associates of Jasper, PC
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Pulmonary Associates, PA
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
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
California Research Medical Group, Inc.
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Radiant Research-Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
West Coast Clinical Trials
City
Newport Beach
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
Institute of Healthcare Assessment, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
San Jose Clinical Research
City
San Jose
State/Province
California
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
Colorado Pulmonary Associates
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Northern Colorado Pulmonary Consultants, PC
City
Fort Collins
State/Province
Colorado
Country
United States
Facility Name
Physicians Research Center, Inc.
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
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
Mt. Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Clinical Pharmacology Services
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Protocare Trial, Inc.
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Marietta Pulmonary Medicine
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Office of Bradley Sakran, MD, PC
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Family Allergy & Asthma Research Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Cumberland Lung and Sleep Specialists
City
Somerset
State/Province
Kentucky
Country
United States
Facility Name
Bendel Medical Associates/Research
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Best Clinical Trials, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
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
New Orleans Center for Clinical Research
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
North Shore Research Associates
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70461
Country
United States
Facility Name
Sunset Medical Research
City
Sunset
State/Province
Louisiana
ZIP/Postal Code
70584
Country
United States
Facility Name
University of Maryland-Airways Research Center
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Institute of Asthma and Allergy
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
Pro-Medica Clinical Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
ClinSite, Inc.
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
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
Country
United States
Facility Name
Montana Medical Research, LLC
City
Missoula
State/Province
Montana
Country
United States
Facility Name
VA Medical Center
City
Omaha
State/Province
Nebraska
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
Pulmonary Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
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
Carolina Pharmaceutical Research, Inc.
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
New Hanover Medical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28412
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
Allergy Associates Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Northeast Clinical Research Centers, Inc.
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Keystone Clinical Solutions
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Philadelphia Health Associates - Adult Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
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
Breath of Life Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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
Bellingham Asthma, Allergy & Immunology Clinic
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
University of Wisconsin-Medical School
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD

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