Status:
TERMINATED
A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
55+ years
Phase:
PHASE4
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 crit...
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 c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2016
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02275481
Start Date
November 1 2014
End Date
September 14 2016
Last Update
June 27 2018
Active Locations (28)
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1
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
2
Clinical Trial Connection
Flagstaff, Arizona, United States, 86001
3
Waterbury Pulmonary Associates LLC
Waterbury, Connecticut, United States, 06708
4
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037