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

Sponsor

Sunovion (Industry)

Overall Status

Completed

CT.gov ID

NCT00064402

Collaborator

(none)

741

Enrollment

Locations

Arms

Duration (Months)

11.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema	Drug: arformoterol tartrate inhalation solution Drug: arformoterol tartrate inhalation solution Drug: arformoterol tartrate inhalation solution Drug: Salmeterol Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

741 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Mar 1, 2004

Actual Study Completion Date :

Mar 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Arformoterol 50 mcg QD and placebo MDI	Drug: arformoterol tartrate inhalation solution arformoterol 50 mcg QD Other Names: (R,R)-formoterol
Experimental: 2 Arformoterol 25 mcg BID and Placebo MDI	Drug: arformoterol tartrate inhalation solution arformoterol 25 mcg BID Other Names: (R,R)-formoterol
Experimental: 3 Arformoterol 15 mcg BID and placebo MDI	Drug: arformoterol tartrate inhalation solution arformoterol 15 mcg BID Other Names: (R,R)-formoterol Brovana
Active Comparator: 4 Salmeterol MDI 42 mcg BID and placebo inhalation solution	Drug: Salmeterol Salmeterol MDI 42 mcg BID Other Names: Serevent MDI
Placebo Comparator: 5 Placebo MDI and placebo inhalation solution	Drug: Placebo Placebo BID

Outcome Measures

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. [Weeks -2, 0, 3, 6, 9, 12]

Secondary Outcome Measures

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]
COPD exacerbations and COPD symptom ratings [Weeks 0-13]
St. George's Hospital Respiratory Questionnaire [Weeks 0, 6, 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulmonary & Sleep Associates of Jasper, PC	Jasper	Alabama	United States	35501
2	Pulmonary Associates, PA	Phoenix	Arizona	United States	85006
3	Arizona Clinical Research Center, Inc.	Tucson	Arizona	United States	85712
4	Northern California Research Corp.	Fair Oaks	California	United States	95628
5	SARC Research Center	Fresno	California	United States	93720
6	California Research Medical Group, Inc.	Fullerton	California	United States	92835
7	Radiant Research-Irvine	Irvine	California	United States	92618
8	West Coast Clinical Trials	Newport Beach	California	United States
9	Center for Clinical Trials, LLC	Paramount	California	United States	90723
10	Advances in Medicine	Rancho Mirage	California	United States	92270
11	Institute of Healthcare Assessment, Inc.	San Diego	California	United States	92120
12	San Jose Clinical Research	San Jose	California	United States
13	Allergy & Asthma Medical Group of Diablo Valley, Inc.	Walnut Creek	California	United States	94598
14	Colorado Pulmonary Associates	Denver	Colorado	United States	80218
15	Northern Colorado Pulmonary Consultants, PC	Fort Collins	Colorado	United States
16	Physicians Research Center, Inc.	Hartford	Connecticut	United States	06106
17	Washington Hospital Center	Washington	District of Columbia	United States
18	Clinical Research of West Florida, Inc.	Clearwater	Florida	United States	33765
19	University Clinical Research, DeLand	DeLand	Florida	United States	32720
20	Mt. Sinai Medical Center	Miami Beach	Florida	United States	33140
21	Clinical Pharmacology Services	Tampa	Florida	United States	33617
22	Protocare Trial, Inc.	Austell	Georgia	United States	30106
23	Marietta Pulmonary Medicine	Marietta	Georgia	United States	30060
24	Office of Bradley Sakran, MD, PC	O'Fallon	Illinois	United States	62269
25	South Bend Clinic	South Bend	Indiana	United States	46617
26	Family Allergy & Asthma Research Institute	Louisville	Kentucky	United States	40215
27	Cumberland Lung and Sleep Specialists	Somerset	Kentucky	United States
28	Bendel Medical Associates/Research	Lafayette	Louisiana	United States	70503
29	Best Clinical Trials, LLC	New Orleans	Louisiana	United States	70115
30	New Orleans Center for Clinical Research	New Orleans	Louisiana	United States	70119
31	New Orleans Center for Clinical Research	New Orleans	Louisiana	United States
32	North Shore Research Associates	Slidell	Louisiana	United States	70461
33	Sunset Medical Research	Sunset	Louisiana	United States	70584
34	University of Maryland-Airways Research Center	Baltimore	Maryland	United States
35	Institute of Asthma and Allergy	Wheaton	Maryland	United States
36	Pro-Medica Clinical Research Center	Boston	Massachusetts	United States	02135
37	ClinSite, Inc.	Ann Arbor	Michigan	United States	48106
38	MedEx HealthCare Research, Inc.	Saint Louis	Missouri	United States	63108
39	Midwest Chest Consultants, PC	St. Charles	Missouri	United States	63301-2847
40	C.A.R.E Clinical Research	St. Louis,	Missouri	United States	63122
41	Office of Keith Popovich, MD	Butte	Montana	United States
42	Montana Medical Research, LLC	Missoula	Montana	United States
43	VA Medical Center	Omaha	Nebraska	United States
44	Advanced Biomedical Research of America	Las Vegas	Nevada	United States	89119
45	Pulmonary Medicine	Chapel Hill	North Carolina	United States	27599
46	Charlotte Lung and Health Center	Charlotte	North Carolina	United States	28207
47	Carolina Pharmaceutical Research, Inc.	Statesville	North Carolina	United States	28625
48	New Hanover Medical Research	Wilmington	North Carolina	United States	28412
49	New Horizons Clinical Research, Inc.	Cincinnati	Ohio	United States	45241
50	COR Clinical Research LLC	Oklahoma City	Oklahoma	United States	73103
51	Allergy Associates Research Center	Portland	Oregon	United States	97213
52	Northeast Clinical Research Centers, Inc.	Allentown	Pennsylvania	United States	18104
53	Keystone Clinical Solutions	Altoona	Pennsylvania	United States	16602
54	Philadelphia Health Associates - Adult Medicine	Philadelphia	Pennsylvania	United States	19146
55	Consortium Clinical Research, Ltd.	Ridley Park	Pennsylvania	United States	19078
56	Safe Harbor Clinical Research	East Providence	Rhode Island	United States	02914
57	Spartanburg Pharmaceutical Research	Spartanburg	South Carolina	United States	29307
58	Volunteer Research Group	Knoxville	Tennessee	United States	37920
59	Breath of Life Research Institute	Houston	Texas	United States	77084
60	Central Texas Health Research	New Braunfels	Texas	United States	78130
61	Sylvana Research Associates	San Antonio	Texas	United States	78229
62	Pulmonary Associates of Fredericksburg, Inc.	Fredericksburg	Virginia	United States	22401
63	Pulmonary Associates of Richmond, Inc.	Richmond	Virginia	United States	23225
64	Bellingham Asthma, Allergy & Immunology Clinic	Bellingham	Washington	United States	98225
65	University of Wisconsin-Medical School	Madison	Wisconsin	United States	53792