Safety Study of Arformoterol Tartrate Inhalation Solution in Chronic Obstructive Pulmonary Disease (COPD) Subjects

NCT ID: NCT00909779

Last Updated: 2013-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 841 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-06-30

Brief Summary

This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation will consist of a total of 6 visits over approximately 1 year.

Detailed Description

This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group, outpatient, safety study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. The administration of arformoterol in subjects with moderate to severe COPD will not result in a meaningfully greater incidence of respiratory death and COPD exacerbation -related hospitalizations compared to placebo (nebulized saline and non-long-acting beta2-agonist [LABA] COPD standard of care treatments). 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease (COPD); respiratory; long-acting beta agonist (LABA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arformoterol 15 mcg twice daily

Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.

Group Type: EXPERIMENTAL

Arformoterol

Intervention Type: DRUG

Arformoterol Tartrate Inhalation Solution 15 mcg twice daily (BID) for a duration of one year

Placebo twice daily

Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo inhalation solution, twice daily (BID) for a duration of one year.

Interventions

Arformoterol

Arformoterol Tartrate Inhalation Solution 15 mcg twice daily (BID) for a duration of one year

Intervention Type: DRUG

Placebo

Placebo inhalation solution, twice daily (BID) for a duration of one year.

Intervention Type: DRUG

Other Intervention Names

Brovana

Eligibility Criteria

Inclusion Criteria

• Subject must give written informed consent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
• Females considered not of childbearing potential must be surgically sterile (total hysterectomy, bilateral salpingo oophorectomy, or tubal ligation) or post-menopausal, which is defined as a complete cessation of menstruation for at least 1 year.
• Male and female subjects must be at least 40 years old at the time of consent.
• Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD.
• Subjects must have a baseline FEV1 of ≤50% predicted volume at Visits 1 and 2 (pre-dose).
• Subjects must have a FEV1 >0.50 L at either Visit 1 or 2 (pre-dose).
• Subject's respiratory status must be clinically stable.
• Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤70% at either Visit 1 or 2 (pre-dose).
• Subjects must have had at least 1 COPD exacerbation within the last year (defined as initiation or an increase in the dose of oral steroids or antibiotics for the treatment of COPD).
• Subjects must have a ≥15 pack-year smoking history and a baseline breathlessness severity grade of ≥2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visit 2.
• Female subjects ≤65 years of age must have a negative serum pregnancy test conducted at Visit 1 prior to randomization. Females of childbearing potential must be using an acceptable method of birth control.
• Subjects' overall health must be sufficiently stable to complete the study requirements based on the screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis), and vital signs (heart rate, respiratory rate, and blood pressure) that have been conducted within 30 days of Visit 2 (randomization). If any of the hematology, chemistry, or urinalysis results are not within the laboratory's reference range, then the subject can be included only if the investigator judges the deviations to be not clinically significant.
• Subjects must have a minimum blood pressure of 105/60 mmHg and a minimum resting pulse of 50 bpm at Screening Visit 1. Subjects who do not meet these criteria at Screening Visit 1 must meet the criteria on the first day of dosing (Day 1) in order to be eligible for the study. Subjects with a medical condition which causes low blood pressure or low heart rate, but, in the opinion of the Principal Investigator or designee the medical condition could resolve, may be rescreened when the condition is resolved.
• Subjects must be willing and able to complete all study questionnaires and logs reliably.
• Subjects must be willing and able to comply with study procedures and visit schedule.
• Subjects must have sufficient understanding of English to complete all questionnaires and logs.

Exclusion Criteria

• Female subjects who are pregnant or lactating.
• Subjects with a history of asthma, with the exception of asthma diagnosed in childhood.
• Subjects with a blood eosinophil count >5% of total white blood cell count.
• Subjects with a febrile illness within 3 days before Screening.
• Subjects with a malignant neoplasm other than non melanomatous basal cell skin cancer. Subjects with a history of malignancy who have been cancer free for 5 years or more may be enrolled.
• Subjects who are currently using disallowed medications or will be unable to complete the medication washout periods. Subjects taking a prohibited concurrent medication which requires a washout of >30 days may be rescreened when the washout of the prohibited concurrent medication has been met.
• Subjects with life threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to screening.
• Subjects who have had a change in dose or type of any medications for COPD within 2 weeks prior to the screening visit. Subjects not on a stable dose of COPD medications may be rescreened after being on a stable dose for at least 14 days
• Subjects with a chest x ray taken ≤3 months prior to screening that suggests a diagnosis other than COPD (eg, diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions). If there is no chest x ray taken ≤3 months prior to screening, or if recent results are unavailable for review, a chest x ray must be performed prior to visit 2. Subjects with a medical condition that caused the abnormal finding, but, in the opinion of the Principal Investigator or designee the medical condition could resolve, may be rescreened when the condition is resolved
• Subjects with a positive urine drug test during screening.
• Subjects with a known history of alcohol abuse may be enrolled in the study if the subject's current alcohol use does not exceed more than 3 alcoholic beverages per day.
• Subjects whose schedule or travel prevents the completion of all required visits.
• Subjects who are scheduled for inpatient hospitalization or elective surgery (inpatient or outpatient) during the trial. Subjects may be rescreened when the condition is resolved.
• Subjects have participated in an investigational drug study and/or any COPD interventional trial within 30 days prior to screening or who are currently participating in another investigational drug study or COPD interventional trial.
• Subjects with a history of allergic reaction to the study medication or any components of the study medications.
• Subjects who are study site staff members or relatives of study site staff members directly involved in this study.
• Subjects with clinically significant cardiac, (Functional Class III and IV; Objective Class C and D by New York Heart Association [NYHA] Functional Classification),hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jefferson Clinic

Birmingham, Alabama, United States

Alabama Clinical Therapeutic, LLC

Birmingham, Alabama, United States

Achieve Clinical Research

Brimingham, Alabama, United States

Jasper Summit Research, LLC

Jasper, Alabama, United States

Chest Critical Care Consultants

Anaheim, California, United States

California Research Medical Group

Fullerton, California, United States

Integrated Research Group

Riverside, California, United States

Quality Control Research Inc.

Roseville, California, United States

Sockolov and Sockolov APC

Sacramento, California, United States

Centers for Clinical Trials of Sacremento

Sacremento, California, United States

Institute of HealthCare Assessment, Inc.

San Diego, California, United States

National Jewish Health

Denver, Colorado, United States

Southeast Clinical Research

Chiefland, Florida, United States

Tampa Bay Medical Research Inc.

Clearwater, Florida, United States

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Avail Clinical Research

DeLand, Florida, United States

The Lung Clinic, P.A.

Kissimmee, Florida, United States

DCT

Orlando, Florida, United States

Clinical Research of West Florida

Tampa, Florida, United States

Canton, Georgia, United States

Southeast Regional Research Group

Columbus, Georgia, United States

Atlanta Pharmaceutical Research

Decatur, Georgia, United States

Wellstar Marietta Pulmonary Medicine

Marietta, Georgia, United States

Southeast Regional Research Group

Rincon, Georgia, United States

Medisphere Medical Research Center

Evansville, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Kentucky Lung Clinic

Hazard, Kentucky, United States

Bendel Medical Research Center, LLC

Lafayette, Louisiana, United States

ClinSite LLC

Ann Arbor, Michigan, United States

Clinical Research Institute Inc.

Minneapolis, Minnesota, United States

Midwest Chest Consultants

Saint Charles, Missouri, United States

C.A.R.E. Clinical Research

St Louis, Missouri, United States

Comprehensive Clinical Research

Berlin, New Jersey, United States

Delaware Valley Clinical Research

Cherry Hill, New Jersey, United States

New York Pulmonary and Clinical Care Associates, PC

New York, New York, United States

ENT & Allergy Associates

Newburgh, New York, United States

Rochester Clinical Research

Rochester, New York, United States

AAIR Research Center

Rochester, New York, United States

American Health Research Inc.

Charlotte, North Carolina, United States

Piedmont Medical Research

Winston-Salem, North Carolina, United States

DayStar Clinical Research, Inc.

Akron, Ohio, United States

Bernstein Clinical Research Center

Cincinnati, Ohio, United States

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, United States

Allergy Associates Research Center

Portland, Oregon, United States

Arcuri Clinical Research, LLC

Philadelphia, Pennsylvania, United States

Biomedical Research Alliance at Hypertension and Nephrology

Pawtucket, Rhode Island, United States

Omega Medical Research

Warwick, Rhode Island, United States

Lowcountry Lung & Critical Care, PA

Charleston, South Carolina, United States

Neem Research Group, Inc.

Columbia, South Carolina, United States

Gaffney Pharmaceutical Research

Gaffney, South Carolina, United States

Greenville Pharmaceutical Research

Greenville, South Carolina, United States

Upstate Pharmaceutical Research

Greenville, South Carolina, United States

Mountain View Clinical Research, Inc.

Greer, South Carolina, United States

S. Carolina Pharmaceutical Research

Spartanburg, South Carolina, United States

CU Pharmaceutical Research

Union, South Carolina, United States

Allergy Associates

Knoxville, Tennessee, United States

Volunteer Research Group

Knoxville, Tennessee, United States

DCT

Arlington, Texas, United States

Baylor College of Medicine, Clinical Studies Unit, Ben Taub General Hospital

Houston, Texas, United States

VAMC

Houston, Texas, United States

Kingwood Research Institute, LLC

Kingwood, Texas, United States

Physician PrimeCare Research

San Antonio, Texas, United States

Diagnostics Research Group

San Antonio, Texas, United States

DCT

Sugar Land, Texas, United States

SouthEast Research Institute

Webster, Texas, United States

National Clinical Resources, Inc.

Provo, Utah, United States

Utah Clinical Trials LLC

Salt Lake City, Utah, United States

Charlottesville Medical Research Inc.

Charlottesville, Virginia, United States

Manassas Clinical Research Center

Manassas, Virginia, United States

Dominion Medical Associates

Richmond, Virginia, United States

Pulmonary Associates of Richmond Inc.

Richmond, Virginia, United States

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, United States

Pulmonary Consultants, PLLC

Tacoma, Washington, United States

Countries

Albania; United States

References

Donohue JF, Ganapathy V, Bollu V, Stensland MD, Nelson LM. Health Status of Patients with Moderate to Severe COPD after Treatment with Nebulized Arformoterol Tartrate or Placebo for 1 Year. Clin Ther. 2017 Jan;39(1):66-74. doi: 10.1016/j.clinthera.2016.11.021. Epub 2016 Dec 20.

Reference Type: DERIVED

PMID: 28011247 (View on PubMed)

Donohue JF, Hanania NA, Make B, Miles MC, Mahler DA, Curry L, Tosiello R, Wheeler A, Tashkin DP. One-year safety and efficacy study of arformoterol tartrate in patients with moderate to severe COPD. Chest. 2014 Dec;146(6):1531-1542. doi: 10.1378/chest.14-0117.

Reference Type: DERIVED

PMID: 25451347 (View on PubMed)

Other Identifiers

091-080

Identifier Type: -

Identifier Source: org_study_id