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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
741
arformoterol 50 mcg QD
arformoterol 25 mcg BID
arformoterol 15 mcg BID
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
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
Peak percent of predicted FEV1
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Weeks -2, 0, 3, 6, 9, 12
peak percent change in FEV1 from visit predose and study baseline
Time frame: Weeks -2, 0, 3, 6, 9, 12
time point changes in FEV1; time to onset of response
Time frame: Weeks -2, 0, 3, 6, 9, 12
time to peak change in FEV1
Time frame: Weeks -2, 0, 3, 6, 9, 12
at-home and in-clinic peak expiratory flow rate (PEFR)
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Salmeterol MDI 42 mcg BID
Placebo BID
Pulmonary & Sleep Associates of Jasper, PC
Jasper, Alabama, United States
Pulmonary Associates, PA
Phoenix, Arizona, United States
Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Northern California Research Corp.
Fair Oaks, California, United States
SARC Research Center
Fresno, California, United States
California Research Medical Group, Inc.
Fullerton, California, United States
Radiant Research-Irvine
Irvine, California, United States
West Coast Clinical Trials
Newport Beach, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
Advances in Medicine
Rancho Mirage, California, United States
...and 55 more locations
Time frame: Weeks -2, 0, 3, 6, 9, 12
relationship between the plasma concentration values and selected pharmacodynamic parameters
Time frame: Weeks -2, 0, 3, 6, 9, 12, 13
Supplemental ipratropium bromide MDI and racemic albuterol MDI use
Time frame: Weeks 0-13
COPD exacerbations and COPD symptom ratings
Time frame: Weeks 0-13
St. George's Hospital Respiratory Questionnaire
Time frame: Weeks 0, 6, 13
Investigator and Subject Global Evaluations
Time frame: Weeks -2, 12, 13
Baseline and Transitional Dyspnea Index
Time frame: Weeks -2, 6, 12
distance walked in six minutes
Time frame: Weeks -2, 3, 9