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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064402
• Other study ID #: 091-051
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2003
• Last updated: February 21, 2012
• Start date: April 2002
• Est. completion date: March 2004

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• arformoterol tartrate inhalation solution
arformoterol 50 mcg QD
• arformoterol tartrate inhalation solution
arformoterol 25 mcg BID
• arformoterol tartrate inhalation solution
arformoterol 15 mcg BID
• Salmeterol
Salmeterol MDI 42 mcg BID
• Placebo
Placebo BID

Locations

Country	Name	City	State
United States	Northeast Clinical Research Centers, Inc.	Allentown	Pennsylvania
United States	Keystone Clinical Solutions	Altoona	Pennsylvania
United States	ClinSite, Inc.	Ann Arbor	Michigan
United States	Protocare Trial, Inc.	Austell	Georgia
United States	University of Maryland-Airways Research Center	Baltimore	Maryland
United States	Bellingham Asthma, Allergy & Immunology Clinic	Bellingham	Washington
United States	Pro-Medica Clinical Research Center	Boston	Massachusetts
United States	Office of Keith Popovich, MD	Butte	Montana
United States	Pulmonary Medicine	Chapel Hill	North Carolina
United States	Charlotte Lung and Health Center	Charlotte	North Carolina
United States	New Horizons Clinical Research, Inc.	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	University Clinical Research, DeLand	DeLand	Florida
United States	Colorado Pulmonary Associates	Denver	Colorado
United States	Safe Harbor Clinical Research	East Providence	Rhode Island
United States	Northern California Research Corp.	Fair Oaks	California
United States	Northern Colorado Pulmonary Consultants, PC	Fort Collins	Colorado
United States	Pulmonary Associates of Fredericksburg, Inc.	Fredericksburg	Virginia
United States	SARC Research Center	Fresno	California
United States	California Research Medical Group, Inc.	Fullerton	California
United States	Physicians Research Center, Inc.	Hartford	Connecticut
United States	Breath of Life Research Institute	Houston	Texas
United States	Radiant Research-Irvine	Irvine	California
United States	Pulmonary & Sleep Associates of Jasper, PC	Jasper	Alabama
United States	Volunteer Research Group	Knoxville	Tennessee
United States	Bendel Medical Associates/Research	Lafayette	Louisiana
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Family Allergy & Asthma Research Institute	Louisville	Kentucky
United States	University of Wisconsin-Medical School	Madison	Wisconsin
United States	Marietta Pulmonary Medicine	Marietta	Georgia
United States	Mt. Sinai Medical Center	Miami Beach	Florida
United States	Montana Medical Research, LLC	Missoula	Montana
United States	Central Texas Health Research	New Braunfels	Texas
United States	Best Clinical Trials, LLC	New Orleans	Louisiana
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	West Coast Clinical Trials	Newport Beach	California
United States	Office of Bradley Sakran, MD, PC	O'Fallon	Illinois
United States	COR Clinical Research LLC	Oklahoma City	Oklahoma
United States	VA Medical Center	Omaha	Nebraska
United States	Center for Clinical Trials, LLC	Paramount	California
United States	Philadelphia Health Associates - Adult Medicine	Philadelphia	Pennsylvania
United States	Pulmonary Associates, PA	Phoenix	Arizona
United States	Allergy Associates Research Center	Portland	Oregon
United States	Advances in Medicine	Rancho Mirage	California
United States	Pulmonary Associates of Richmond, Inc.	Richmond	Virginia
United States	Consortium Clinical Research, Ltd.	Ridley Park	Pennsylvania
United States	MedEx HealthCare Research, Inc.	Saint Louis	Missouri
United States	Sylvana Research Associates	San Antonio	Texas
United States	Institute of Healthcare Assessment, Inc.	San Diego	California
United States	San Jose Clinical Research	San Jose	California
United States	North Shore Research Associates	Slidell	Louisiana
United States	Cumberland Lung and Sleep Specialists	Somerset	Kentucky
United States	South Bend Clinic	South Bend	Indiana
United States	Spartanburg Pharmaceutical Research	Spartanburg	South Carolina
United States	Midwest Chest Consultants, PC	St. Charles	Missouri
United States	C.A.R.E Clinical Research	St. Louis,	Missouri
United States	Carolina Pharmaceutical Research, Inc.	Statesville	North Carolina
United States	Sunset Medical Research	Sunset	Louisiana
United States	Clinical Pharmacology Services	Tampa	Florida
United States	Arizona Clinical Research Center, Inc.	Tucson	Arizona
United States	Allergy & Asthma Medical Group of Diablo Valley, Inc.	Walnut Creek	California
United States	Washington Hospital Center	Washington	District of Columbia
United States	Institute of Asthma and Allergy	Wheaton	Maryland
United States	New Hanover Medical Research	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Peak percent of predicted FEV1		Weeks -2, 0, 3, 6, 9, 12	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	peak percent change in FEV1 from visit predose and study baseline		Weeks -2, 0, 3, 6, 9, 12	No
Secondary	time point changes in FEV1; time to onset of response		Weeks -2, 0, 3, 6, 9, 12	No
Secondary	time to peak change in FEV1		Weeks -2, 0, 3, 6, 9, 12	No
Secondary	at-home and in-clinic peak expiratory flow rate (PEFR)		Weeks -2, 0, 3, 6, 9, 12	No
Secondary	relationship between the plasma concentration values and selected pharmacodynamic parameters		Weeks -2, 0, 3, 6, 9, 12, 13	No
Secondary	Supplemental ipratropium bromide MDI and racemic albuterol MDI use		Weeks 0-13	No
Secondary	COPD exacerbations and COPD symptom ratings		Weeks 0-13	Yes
Secondary	St. George's Hospital Respiratory Questionnaire		Weeks 0, 6, 13	Yes
Secondary	Investigator and Subject Global Evaluations		Weeks -2, 12, 13	Yes
Secondary	Baseline and Transitional Dyspnea Index		Weeks -2, 6, 12	Yes
Secondary	distance walked in six minutes		Weeks -2, 3, 9	Yes