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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02275481
• Other study ID #: SEP091-402
• Status: Terminated
• Phase: Phase 4
• Start date: November 2014
• Est. completion date: September 14, 2016

Study information

• Verified date: June 2018
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: September 14, 2016
• Est. primary completion date: September 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Birmingham VA Medical Center	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	VA Western New York Healthcare System	Buffalo	New York
United States	Cincinnati Veterans Affairs Medical Center	Cincinnati	Ohio
United States	Remington-Davis, Inc.	Columbus	Ohio
United States	Clinical Trial Connection	Flagstaff	Arizona
United States	Southeastern Intergrted Medical, PL d/b/a Florida Medical Research	Gainesville	Florida
United States	Clinical Research of Gastonia	Gastonia	North Carolina
United States	Gastonia Phannaceutical Research	Gastonia	North Carolina
United States	Upstate Pharmaceutical Research	Greenville	South Carolina
United States	Clinical Research of Lake Norman	Huntersville	North Carolina
United States	Family Medicine Rural Health Clinic, PA, DBA FMC Science	Lampasas	Texas
United States	Gwinnett Biomedical Research	Lawrenceville	Georgia
United States	Metroplex Pulmonary and Sleep Center	McKinney	Texas
United States	Miami VA Medical Center	Miami	Florida
United States	Consolidated Clinical Trials, Inc.	Monroeville	Pennsylvania
United States	Mid State Pulmonary	Nashville	Tennessee
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Temple University Hospital, Temple Lung Center	Philadelphia	Pennsylvania
United States	Clinical Research of Rock Hill	Rock Hill	South Carolina
United States	Alamo Clinical Research Associates	San Antonio	Texas
United States	Swedish Medical Center	Seattle	Washington
United States	S. Carolina Pharmaceutical Research	Spartanburg	South Carolina
United States	George Washington University Medical Faculty Associates	Washington	District of Columbia
United States	Waterbury Pulmonary Associates LLC	Waterbury	Connecticut
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Southeastern Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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