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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema
• Interventions: Drug: arformoterol tartrate inhalation solution; Drug: Salmeterol; Drug: Placebo

• Registration Number: NCT00064402
• Lead Sponsor: Sumitomo Pharma America, Inc.

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.

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2003-07-08
• Study First Submitted QC: 2003-07-08
• Study First Posted: 2003-07-09
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 741

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	arformoterol tartrate inhalation solution	Arformoterol 15 mcg BID and placebo MDI
4	Salmeterol	Salmeterol MDI 42 mcg BID and placebo inhalation solution
5	Placebo	Placebo MDI and placebo inhalation solution
2	arformoterol tartrate inhalation solution	Arformoterol 25 mcg BID and Placebo MDI
1	arformoterol tartrate inhalation solution	Arformoterol 50 mcg QD and placebo MDI

Primary Outcome Measures

Name	Time	Method
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.	Weeks -2, 0, 3, 6, 9, 12

Secondary Outcome Measures

Name	Time	Method
COPD exacerbations and COPD symptom ratings	Weeks 0-13
St. George's Hospital Respiratory Questionnaire	Weeks 0, 6, 13
time-normalized area under the percent change from visit predose curve for FEV1 over 12 hours (nAUC0-12-P)	Weeks -2, 0, 3, 6, 9, 12
Peak percent of predicted FEV1	Weeks -2, 0, 3, 6, 9, 12
time-normalized area under the percent change in FEV1 from study baseline over 12 hours (nAUC0-12-B)	Weeks -2, 0, 3, 6, 9, 12
time-normalized area under the percent change from visit predose curve for FEV1 over 24 hours (nAUC0-24-P)	Weeks -2, 0, 3, 6, 9, 12
time-normalized area under the percent change in FEV1 from study baseline curve over 24 hours (nAUC0-24-B)	Weeks -2, 0, 3, 6, 9, 12
peak percent change in FEV1 from visit predose and study baseline	Weeks -2, 0, 3, 6, 9, 12
time point changes in FEV1; time to onset of response	Weeks -2, 0, 3, 6, 9, 12
time to peak change in FEV1	Weeks -2, 0, 3, 6, 9, 12
at-home and in-clinic peak expiratory flow rate (PEFR)	Weeks -2, 0, 3, 6, 9, 12
relationship between the plasma concentration values and selected pharmacodynamic parameters	Weeks -2, 0, 3, 6, 9, 12, 13
Supplemental ipratropium bromide MDI and racemic albuterol MDI use	Weeks 0-13
Investigator and Subject Global Evaluations	Weeks -2, 12, 13
Baseline and Transitional Dyspnea Index	Weeks -2, 6, 12
distance walked in six minutes	Weeks -2, 3, 9

Trial Locations

Locations (64)

Advances in Medicine; 🇺🇸 Rancho Mirage, California, United States

Office of Bradley Sakran, MD, PC; 🇺🇸 O'Fallon, Illinois, United States

University of Maryland-Airways Research Center; 🇺🇸 Baltimore, Maryland, United States

Pro-Medica Clinical Research Center; 🇺🇸 Boston, Massachusetts, United States

Breath of Life Research Institute; 🇺🇸 Houston, Texas, United States

Pulmonary Associates of Fredericksburg, Inc.; 🇺🇸 Fredericksburg, Virginia, United States

Advanced Biomedical Research of America; 🇺🇸 Las Vegas, Nevada, United States

Institute of Healthcare Assessment, Inc.; 🇺🇸 San Diego, California, United States

New Horizons Clinical Research, Inc.; 🇺🇸 Cincinnati, Ohio, United States

Sylvana Research Associates; 🇺🇸 San Antonio, Texas, United States

Pulmonary Associates, PA; 🇺🇸 Phoenix, Arizona, United States

SARC Research Center; 🇺🇸 Fresno, California, United States

Pulmonary & Sleep Associates of Jasper, PC; 🇺🇸 Jasper, Alabama, United States

Safe Harbor Clinical Research; 🇺🇸 East Providence, Rhode Island, United States

Central Texas Health Research; 🇺🇸 New Braunfels, Texas, United States

Volunteer Research Group; 🇺🇸 Knoxville, Tennessee, United States

Colorado Pulmonary Associates; 🇺🇸 Denver, Colorado, United States

Clinical Pharmacology Services; 🇺🇸 Tampa, Florida, United States

COR Clinical Research LLC; 🇺🇸 Oklahoma City, Oklahoma, United States

Allergy Associates Research Center; 🇺🇸 Portland, Oregon, United States

Northern California Research Corp.; 🇺🇸 Fair Oaks, California, United States

California Research Medical Group, Inc.; 🇺🇸 Fullerton, California, United States

West Coast Clinical Trials; 🇺🇸 Newport Beach, California, United States

Center for Clinical Trials, LLC; 🇺🇸 Paramount, California, United States

Radiant Research-Irvine; 🇺🇸 Irvine, California, United States

San Jose Clinical Research; 🇺🇸 San Jose, California, United States

Northern Colorado Pulmonary Consultants, PC; 🇺🇸 Fort Collins, Colorado, United States

Clinical Research of West Florida, Inc.; 🇺🇸 Clearwater, Florida, United States

Allergy & Asthma Medical Group of Diablo Valley, Inc.; 🇺🇸 Walnut Creek, California, United States

University Clinical Research, DeLand; 🇺🇸 DeLand, Florida, United States

Protocare Trial, Inc.; 🇺🇸 Austell, Georgia, United States

Marietta Pulmonary Medicine; 🇺🇸 Marietta, Georgia, United States

South Bend Clinic; 🇺🇸 South Bend, Indiana, United States

Cumberland Lung and Sleep Specialists; 🇺🇸 Somerset, Kentucky, United States

Mt. Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Bendel Medical Associates/Research; 🇺🇸 Lafayette, Louisiana, United States

North Shore Research Associates; 🇺🇸 Slidell, Louisiana, United States

Institute of Asthma and Allergy; 🇺🇸 Wheaton, Maryland, United States

MedEx HealthCare Research, Inc.; 🇺🇸 Saint Louis, Missouri, United States

Montana Medical Research, LLC; 🇺🇸 Missoula, Montana, United States

Midwest Chest Consultants, PC; 🇺🇸 St. Charles, Missouri, United States

Office of Keith Popovich, MD; 🇺🇸 Butte, Montana, United States

Charlotte Lung and Health Center; 🇺🇸 Charlotte, North Carolina, United States

VA Medical Center; 🇺🇸 Omaha, Nebraska, United States

C.A.R.E Clinical Research; 🇺🇸 St. Louis,, Missouri, United States

New Hanover Medical Research; 🇺🇸 Wilmington, North Carolina, United States

Keystone Clinical Solutions; 🇺🇸 Altoona, Pennsylvania, United States

Carolina Pharmaceutical Research, Inc.; 🇺🇸 Statesville, North Carolina, United States

Northeast Clinical Research Centers, Inc.; 🇺🇸 Allentown, Pennsylvania, United States

Philadelphia Health Associates - Adult Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

Consortium Clinical Research, Ltd.; 🇺🇸 Ridley Park, Pennsylvania, United States

Spartanburg Pharmaceutical Research; 🇺🇸 Spartanburg, South Carolina, United States

Bellingham Asthma, Allergy & Immunology Clinic; 🇺🇸 Bellingham, Washington, United States

University of Wisconsin-Medical School; 🇺🇸 Madison, Wisconsin, United States

Arizona Clinical Research Center, Inc.; 🇺🇸 Tucson, Arizona, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Physicians Research Center, Inc.; 🇺🇸 Hartford, Connecticut, United States

Sunset Medical Research; 🇺🇸 Sunset, Louisiana, United States

ClinSite, Inc.; 🇺🇸 Ann Arbor, Michigan, United States

Family Allergy & Asthma Research Institute; 🇺🇸 Louisville, Kentucky, United States

Best Clinical Trials, LLC; 🇺🇸 New Orleans, Louisiana, United States

New Orleans Center for Clinical Research; 🇺🇸 New Orleans, Louisiana, United States

Pulmonary Medicine; 🇺🇸 Chapel Hill, North Carolina, United States

Pulmonary Associates of Richmond, Inc.; 🇺🇸 Richmond, Virginia, United States