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

NCT ID: NCT02275481

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-09-14

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BROVANA

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

Group Type: EXPERIMENTAL

Arformoterol tartrate inhalation solution

Intervention Type: DRUG

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 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.

Group Type: ACTIVE_COMPARATOR

Tiotropium

Intervention Type: DRUG

Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.

Interventions

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

Intervention Type: DRUG

Tiotropium

Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.

Intervention Type: DRUG

Other Intervention Names

BROVANA; SPIRIVA

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Respiratory Medical Director, MD

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

Birmingham VA Medical Center

Birmingham, Alabama, United States

Clinical Trial Connection

Flagstaff, Arizona, United States

Waterbury Pulmonary Associates LLC

Waterbury, Connecticut, United States

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, United States

Southeastern Intergrted Medical, PL d/b/a Florida Medical Research

Gainesville, Florida, United States

Miami VA Medical Center

Miami, Florida, United States

Gwinnett Biomedical Research

Lawrenceville, Georgia, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

VA Western New York Healthcare System

Buffalo, New York, United States

Clinical Research of Gastonia

Gastonia, North Carolina, United States

Gastonia Phannaceutical Research

Gastonia, North Carolina, United States

Clinical Research of Lake Norman

Huntersville, North Carolina, United States

PMG Research of Wilmington

Wilmington, North Carolina, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

Cincinnati Veterans Affairs Medical Center

Cincinnati, Ohio, United States

Remington-Davis, Inc.

Columbus, Ohio, United States

Consolidated Clinical Trials, Inc.

Monroeville, Pennsylvania, United States

Temple University Hospital, Temple Lung Center

Philadelphia, Pennsylvania, United States

Upstate Pharmaceutical Research

Greenville, South Carolina, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

S. Carolina Pharmaceutical Research

Spartanburg, South Carolina, United States

Mid State Pulmonary

Nashville, Tennessee, United States

Family Medicine Rural Health Clinic, PA, DBA FMC Science

Lampasas, Texas, United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas, United States

Alamo Clinical Research Associates

San Antonio, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

SEP091-402

Identifier Type: -

Identifier Source: org_study_id