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

Tracking Information
First Submitted Date ICMJE	July 8, 2003
First Posted Date ICMJE	July 9, 2003
Last Update Posted Date	February 22, 2012
Study Start Date ICMJE	April 2002
Actual Primary Completion Date	March 2004 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 6, 2008)	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 ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00064402 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 6, 2008)	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) [ 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 ]
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD
Official Title ICMJE	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
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 Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema
Intervention ICMJE	Drug: arformoterol tartrate inhalation solution arformoterol 50 mcg QD Other Name: (R,R)-formoterol; Drug: arformoterol tartrate inhalation solution arformoterol 25 mcg BID Other Name: (R,R)-formoterol; Drug: arformoterol tartrate inhalation solution arformoterol 15 mcg BID Other Names: (R,R)-formoterol Brovana; Drug: Salmeterol Salmeterol MDI 42 mcg BID Other Name: Serevent MDI; Drug: Placebo Placebo BID
Study Arms	Experimental: 1 Arformoterol 50 mcg QD and placebo MDI Intervention: Drug: arformoterol tartrate inhalation solution; Experimental: 2 Arformoterol 25 mcg BID and Placebo MDI Intervention: Drug: arformoterol tartrate inhalation solution; Experimental: 3 Arformoterol 15 mcg BID and placebo MDI Intervention: Drug: arformoterol tartrate inhalation solution; Active Comparator: 4 Salmeterol MDI 42 mcg BID and placebo inhalation solution Intervention: Drug: Salmeterol; Placebo Comparator: 5 Placebo MDI and placebo inhalation solution Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 6, 2008)	741
Original Enrollment ICMJE; (submitted: June 23, 2005)	800
Actual Study Completion Date	March 2004
Actual Primary Completion Date	March 2004 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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)
Sex/Gender	Sexes Eligible for Study: All
Ages	35 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00064402
Other Study ID Numbers ICMJE	091-051
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Sunovion
Study Sponsor ICMJE	Sunovion
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Sunovion
Verification Date	February 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP