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



Status:Terminated
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:55 - Any
Updated:6/29/2018
Start Date:November 2014
End Date:September 14, 2016

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

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.

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.

Inclusion Criteria:

1. 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:

1. 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

2. Subject has had oxygen therapy use within 3 months prior to study entry.

2. 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).

3. Subject is willing and able to attend study visits/telephone contacts and adhere to
all study assessments/procedures.

4. Subject is willing and able to provide written informed consent.

Exclusion Criteria:

1. 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.

2. Subject has a primary diagnosis of asthma.

3. Subject has a history of tuberculosis, bronchiectasis or other non-specific pulmonary
disease.

4. Subject has a history of urinary retention or bladder neck obstruction type symptoms.

5. Subject has a history of narrow angle glaucoma.

6. Subject has a recent history (previous 12 months) of excessive use or abuse of alcohol
or narcotic/illegal drugs, as assessed by the Investigator.

7. Subject has a history of hypersensitivity or intolerance to aerosol medications,
beta-2 agonists, or anticholinergics.

8. 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.

9. Subject is a staff member of the clinical site or a relative of a clinical site staff
member.
We found this trial at
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Waterbury, Connecticut
Phone: 203-759-3656
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-7420
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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30 Pointe Circle
Greenville, South Carolina 29615
(864)255-3540
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1201 Northwest 16th St # B822
Miami, Florida 33125
Phone: 305-575-7000
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Phone: 401-328-8141
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Birmingham, Alabama 35233
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Buffalo, New York 14215
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Cincinnati, Ohio 45220
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Columbus, Ohio 43215
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Flagstaff, Arizona 86001
Phone: 928-637-6614
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Gainesville, Florida 32607
Phone: 352-333-8990
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Gastonia, North Carolina 28054
Phone: 704-675-7144
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Gastonia, North Carolina 28054
Phone: 704-867-8980
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Huntersville, North Carolina 28078
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Lampasas, Texas 76550
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Lawrenceville, Georgia 30046
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McKinney, Texas 75069
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Monroeville, Pennsylvania 15146
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Nashville, Tennessee 37203
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Phone: 402-559-8832
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Philadelphia, Pennsylvania 19140
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Rock Hill, South Carolina 29732
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San Antonio, Texas 78212
Phone: 210-223-3010
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Phone: 206-215-3063
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Spartanburg, South Carolina 29303
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Washington, District of Columbia 20037
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
Phone: 910-133-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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Winston-Salem, North Carolina 27103
Phone: 336-659-8414
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