Clinical trial NCT00064402: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2003-07-09
Enrollment: 741
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: 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.

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)

Primary outcomes:
measure: 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.
timeFrame: Weeks -2, 0, 3, 6, 9, 12
Secondary outcomes:
measure: time-normalized area under the percent change from visit predose curve for FEV1 over 12 hours (nAUC0-12-P)
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 in FEV1 from study baseline over 12 hours (nAUC0-12-B)
timeFrame: Weeks -2, 0, 3, 6, 9, 12
measure: time-normalized area under the percent change from visit predose curve for FEV1 over 24 hours (nAUC0-24-P)
timeFrame: Weeks -2, 0, 3, 6, 9, 12
measure: time-normalized area under the percent change in FEV1 from study baseline curve over 24 hours (nAUC0-24-B)
timeFrame: Weeks -2, 0, 3, 6, 9, 12
measure: peak percent change in FEV1 from visit predose and study baseline
timeFrame: Weeks -2, 0, 3, 6, 9, 12
measure: time point changes in FEV1; 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, 3, 6, 9, 12
measure: relationship between the plasma concentration values and selected pharmacodynamic parameters
timeFrame: Weeks -2, 0, 3, 6, 9, 12, 13
measure: Supplemental ipratropium bromide MDI and racemic albuterol MDI use
timeFrame: Weeks 0-13
measure: COPD exacerbations and COPD symptom ratings
timeFrame: Weeks 0-13
measure: St. George's Hospital Respiratory Questionnaire
timeFrame: Weeks 0, 6, 13
measure: Investigator and Subject Global Evaluations
timeFrame: Weeks -2, 12, 13
measure: Baseline and Transitional Dyspnea Index
timeFrame: Weeks -2, 6, 12
measure: distance walked in six minutes
timeFrame: Weeks -2, 3, 9
Other outcomes:
Locations:
city: Jasper
country: United States
facility: Pulmonary & Sleep Associates of Jasper, PC
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates, PA
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center, Inc.
state: Arizona
city: Fair Oaks
country: United States
facility: Northern California Research Corp.
state: California
city: Fresno
country: United States
facility: SARC Research Center
state: California
city: Fullerton
country: United States
facility: California Research Medical Group, Inc.
state: California
city: Irvine
country: United States
facility: Radiant Research-Irvine
state: California
city: Newport Beach
country: United States
facility: West Coast Clinical Trials
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Rancho Mirage
country: United States
facility: Advances in Medicine
state: California
city: San Diego
country: United States
facility: Institute of Healthcare Assessment, Inc.
state: California
city: San Jose
country: United States
facility: San Jose Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Medical Group of Diablo Valley, Inc.
state: California
city: Denver
country: United States
facility: Colorado Pulmonary Associates
state: Colorado
city: Fort Collins
country: United States
facility: Northern Colorado Pulmonary Consultants, PC
state: Colorado
city: Hartford
country: United States
facility: Physicians Research Center, Inc.
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: DeLand
country: United States
facility: University Clinical Research, DeLand
state: Florida
city: Miami Beach
country: United States
facility: Mt. Sinai Medical Center
state: Florida
city: Tampa
country: United States
facility: Clinical Pharmacology Services
state: Florida
city: Austell
country: United States
facility: Protocare Trial, Inc.
state: Georgia
city: Marietta
country: United States
facility: Marietta Pulmonary Medicine
state: Georgia
city: O'Fallon
country: United States
facility: Office of Bradley Sakran, MD, PC
state: Illinois
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Louisville
country: United States
facility: Family Allergy & Asthma Research Institute
state: Kentucky
city: Somerset
country: United States
facility: Cumberland Lung and Sleep Specialists
state: Kentucky
city: Lafayette
country: United States
facility: Bendel Medical Associates/Research
state: Louisiana
city: New Orleans
country: United States
facility: Best Clinical Trials, LLC
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Slidell
country: United States
facility: North Shore Research Associates
state: Louisiana
city: Sunset
country: United States
facility: Sunset Medical Research
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland-Airways Research Center
state: Maryland
city: Wheaton
country: United States
facility: Institute of Asthma and Allergy
state: Maryland
city: Boston
country: United States
facility: Pro-Medica Clinical Research Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: ClinSite, Inc.
state: Michigan
city: Saint Louis
country: United States
facility: MedEx HealthCare Research, Inc.
state: Missouri
city: St. Charles
country: United States
facility: Midwest Chest Consultants, PC
state: Missouri
city: St. Louis,
country: United States
facility: C.A.R.E Clinical Research
state: Missouri
city: Butte
country: United States
facility: Office of Keith Popovich, MD
state: Montana
city: Missoula
country: United States
facility: Montana Medical Research, LLC
state: Montana
city: Omaha
country: United States
facility: VA Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Chapel Hill
country: United States
facility: Pulmonary Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Lung and Health Center
state: North Carolina
city: Statesville
country: United States
facility: Carolina Pharmaceutical Research, Inc.
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Medical Research
state: North Carolina
city: Cincinnati
country: United States
facility: New Horizons Clinical Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research LLC
state: Oklahoma
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Allentown
country: United States
facility: Northeast Clinical Research Centers, Inc.
state: Pennsylvania
city: Altoona
country: United States
facility: Keystone Clinical Solutions
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Health Associates - Adult Medicine
state: Pennsylvania
city: Ridley Park
country: United States
facility: Consortium Clinical Research, Ltd.
state: Pennsylvania
city: East Providence
country: United States
facility: Safe Harbor Clinical Research
state: Rhode Island
city: Spartanburg
country: United States
facility: Spartanburg Pharmaceutical Research
state: South Carolina
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Houston
country: United States
facility: Breath of Life Research Institute
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Fredericksburg
country: United States
facility: Pulmonary Associates of Fredericksburg, Inc.
state: Virginia
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond, Inc.
state: Virginia
city: Bellingham
country: United States
facility: Bellingham Asthma, Allergy & Immunology Clinic
state: Washington
city: Madison
country: United States
facility: University of Wisconsin-Medical School
state: Wisconsin
Study officials:
References: