A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Registration Number
- NCT02275481
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
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.
- Detailed Description
This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD subjects who are discharged from the hospital following a COPD exacerbation. Subjects who meet the eligibility criteria will be randomized to 1 of 2 treatments. Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor. Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Study medications will be dispensed to the subject at Visit 1. The objective of the study is to determine the comparative effectiveness of arformoterol and tiotropium on re-hospitalization and to assess safety in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 66
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BROVANA Arformoterol tartrate inhalation solution Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor SPIRIVA Tiotropium Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing All-cause Hospitalization or Emergency Department Visit Within 90-days of Initiating Treatment Up to 90 days Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only summary tables and listings, disposition, demographics, vital signs, AEs and listings of safety data were generated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
S. Carolina Pharmaceutical Research
🇺🇸Spartanburg, South Carolina, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Temple University Hospital, Temple Lung Center
🇺🇸Philadelphia, Pennsylvania, United States
Remington-Davis, Inc.
🇺🇸Columbus, Ohio, United States
Miami VA Medical Center
🇺🇸Miami, Florida, United States
Clinical Trial Connection
🇺🇸Flagstaff, Arizona, United States
Clinical Research of Lake Norman
🇺🇸Huntersville, North Carolina, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
Gwinnett Biomedical Research
🇺🇸Lawrenceville, Georgia, United States
Gastonia Phannaceutical Research
🇺🇸Gastonia, North Carolina, United States
Consolidated Clinical Trials, Inc.
🇺🇸Monroeville, Pennsylvania, United States
VA Western New York Healthcare System
🇺🇸Buffalo, New York, United States
Clinical Research of Rock Hill
🇺🇸Rock Hill, South Carolina, United States
Family Medicine Rural Health Clinic, PA, DBA FMC Science
🇺🇸Lampasas, Texas, United States
Metroplex Pulmonary and Sleep Center
🇺🇸McKinney, Texas, United States
Birmingham VA Medical Center
🇺🇸Birmingham, Alabama, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Cincinnati Veterans Affairs Medical Center
🇺🇸Cincinnati, Ohio, United States
Mid State Pulmonary
🇺🇸Nashville, Tennessee, United States
Alamo Clinical Research Associates
🇺🇸San Antonio, Texas, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Waterbury Pulmonary Associates LLC
🇺🇸Waterbury, Connecticut, United States
Upstate Pharmaceutical Research
🇺🇸Greenville, South Carolina, United States
George Washington University Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Southeastern Intergrted Medical, PL d/b/a Florida Medical Research
🇺🇸Gainesville, Florida, United States
Southeastern Research Center
🇺🇸Winston-Salem, North Carolina, United States