Study Stopped
lack of enrollment
A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects
A Comparative Effectiveness and Safety Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects
1 other identifier
interventional
66
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2014
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2014
CompletedFirst Posted
Study publicly available on registry
October 27, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2016
CompletedResults Posted
Study results publicly available
October 2, 2017
CompletedJune 27, 2018
June 1, 2018
1.9 years
October 23, 2014
September 5, 2017
June 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Experiencing All-cause Hospitalization or Emergency Department Visit Within 90-days of Initiating Treatment
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.
Up to 90 days
Study Arms (2)
BROVANA
EXPERIMENTALArformoterol 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
ACTIVE COMPARATORTiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Interventions
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®.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Birmingham VA Medical Center
Birmingham, Alabama, 35233, United States
Clinical Trial Connection
Flagstaff, Arizona, 86001, United States
Waterbury Pulmonary Associates LLC
Waterbury, Connecticut, 06708, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Southeastern Intergrted Medical, PL d/b/a Florida Medical Research
Gainesville, Florida, 32607, United States
Miami VA Medical Center
Miami, Florida, 33125, United States
Gwinnett Biomedical Research
Lawrenceville, Georgia, 30046, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
VA Western New York Healthcare System
Buffalo, New York, 14215, United States
Clinical Research of Gastonia
Gastonia, North Carolina, 28054, United States
Gastonia Phannaceutical Research
Gastonia, North Carolina, 28054, United States
Clinical Research of Lake Norman
Huntersville, North Carolina, 28078, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103, United States
Cincinnati Veterans Affairs Medical Center
Cincinnati, Ohio, 45220, United States
Remington-Davis, Inc.
Columbus, Ohio, 43215, United States
Consolidated Clinical Trials, Inc.
Monroeville, Pennsylvania, 15146, United States
Temple University Hospital, Temple Lung Center
Philadelphia, Pennsylvania, 19140, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732, United States
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, 29303, United States
Mid State Pulmonary
Nashville, Tennessee, 37203, United States
Family Medicine Rural Health Clinic, PA, DBA FMC Science
Lampasas, Texas, 76550, United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas, 75069, United States
Alamo Clinical Research Associates
San Antonio, Texas, 78212, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
study was terminated early due to lack of enrollment
Results Point of Contact
- Title
- Respiratory Medical Director
- Organization
- Sunovion Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Respiratory Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2014
First Posted
October 27, 2014
Study Start
November 1, 2014
Primary Completion
September 14, 2016
Study Completion
September 14, 2016
Last Updated
June 27, 2018
Results First Posted
October 2, 2017
Record last verified: 2018-06