A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects

Stopped early · Phase 4

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD subjects who are discharged from the hospital due to a COPD exacerbation. Subjects who meet the eligibility criteria will be randomized to 1 of 2 treatments: arformoterol tartrate inhalation solution (BROVANA) 15 mcg twice daily (BID) or tiotropium bromide (SPIRIVA) 18 mcg once daily (QD), each given for 90 days.

Key facts

Study ID

NCT02275481

Run by

Sumitomo Pharma America, Inc.

People needed

66

Starts

2014-11-01

Expected to finish

2016-09-14

Last updated by the study team

2018-06-27

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects ≥ 55 years-old are eligible for study participation if they have a physician-assessed diagnosis of COPD, have been discharged from the hospital due to a COPD exacerbation, and at least 1 of the following:
• Subject has had 1 or more exacerbations (excluding current exacerbation) within the previous year (exacerbation defined as: an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and /or sputum beyond day to day variability sufficient to warrant a change in management of COPD (eg, treated with antibiotics and/or systemic corticosteroids or requiring an emergency room visit or an overnight stay at a hospital), OR
• Subject has had oxygen therapy use within 3 months prior to study entry.
• Subject is a current or ex-smoker with at least 10 pack year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
• Subject is willing and able to attend study visits/telephone contacts and adhere to all study assessments/procedures.
• Subject is willing and able to provide written informed consent.

You may not qualify if…

• Subject has current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
• Subject has a primary diagnosis of asthma.
• Subject has a history of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
• Subject has a history of urinary retention or bladder neck obstruction type symptoms.
• Subject has a history of narrow angle glaucoma.
• Subject has a recent history (previous 12 months) of excessive use or abuse of alcohol or narcotic/illegal drugs, as assessed by the Investigator.
• Subject has a history of hypersensitivity or intolerance to aerosol medications, beta-2 agonists, or anticholinergics.
• Subject is participating in another investigational drug study where drug was received within 30 days prior to Screening, or current participation in another investigational drug trial.
• Subject is a staff member of the clinical site or a relative of a clinical site staff member.

Where it is running

• Birmingham VA Medical Center — Birmingham, Alabama, United States
• Clinical Trial Connection — Flagstaff, Arizona, United States
• Waterbury Pulmonary Associates LLC — Waterbury, Connecticut, United States
• George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Southeastern Intergrted Medical, PL d/b/a Florida Medical Research — Gainesville, Florida, United States
• Miami VA Medical Center — Miami, Florida, United States
• Gwinnett Biomedical Research — Lawrenceville, Georgia, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• VA Western New York Healthcare System — Buffalo, New York, United States
• Clinical Research of Gastonia — Gastonia, North Carolina, United States
• Gastonia Phannaceutical Research — Gastonia, North Carolina, United States
• Clinical Research of Lake Norman — Huntersville, North Carolina, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• Southeastern Research Center — Winston-Salem, North Carolina, United States
• Cincinnati Veterans Affairs Medical Center — Cincinnati, Ohio, United States
• Remington-Davis, Inc. — Columbus, Ohio, United States
• Consolidated Clinical Trials, Inc. — Monroeville, Pennsylvania, United States
• Temple University Hospital, Temple Lung Center — Philadelphia, Pennsylvania, United States
• Upstate Pharmaceutical Research — Greenville, South Carolina, United States
• Clinical Research of Rock Hill — Rock Hill, South Carolina, United States
• S. Carolina Pharmaceutical Research — Spartanburg, South Carolina, United States
• Mid State Pulmonary — Nashville, Tennessee, United States
• Family Medicine Rural Health Clinic, PA, DBA FMC Science — Lampasas, Texas, United States

Full record on ClinicalTrials.gov

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