Clinical trial NCT02275481: A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects
Official title: A Comparative Effectiveness and Safety Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease
COPD
Emphysema
Chronic bronchitis
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 66
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Experiencing All-cause Hospitalization or Emergency Department Visit Within 90-days of Initiating Treatment
timeFrame: Up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center
state: Alabama
city: Flagstaff
country: United States
facility: Clinical Trial Connection
state: Arizona
city: Waterbury
country: United States
facility: Waterbury Pulmonary Associates LLC
state: Connecticut
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Gainesville
country: United States
facility: Southeastern Intergrted Medical, PL d/b/a Florida Medical Research
state: Florida
city: Miami
country: United States
facility: Miami VA Medical Center
state: Florida
city: Lawrenceville
country: United States
facility: Gwinnett Biomedical Research
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Buffalo
country: United States
facility: VA Western New York Healthcare System
state: New York
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Gastonia
country: United States
facility: Gastonia Phannaceutical Research
state: North Carolina
city: Huntersville
country: United States
facility: Clinical Research of Lake Norman
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Veterans Affairs Medical Center
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis, Inc.
state: Ohio
city: Monroeville
country: United States
facility: Consolidated Clinical Trials, Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital, Temple Lung Center
state: Pennsylvania
city: Greenville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Spartanburg
country: United States
facility: S. Carolina Pharmaceutical Research
state: South Carolina
city: Nashville
country: United States
facility: Mid State Pulmonary
state: Tennessee
city: Lampasas
country: United States
facility: Family Medicine Rural Health Clinic, PA, DBA FMC Science
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center
state: Texas
city: San Antonio
country: United States
facility: Alamo Clinical Research Associates
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Respiratory Medical Director, MD
role: STUDY_DIRECTOR
References: