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

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)

Intervention: Arformoterol tartrate inhalation solution (Drug); Tiotropium (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sunovion

Official(s) and/or principal investigator(s):
Respiratory Medical Director, MD, Study Director, Affiliation: Sunovion

Overall contact:
Study Manager, Phone: 1-866-503-6351

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The rate of all-cause hospitalization or Emergency Department visit within 90-days of initiating treatment.

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

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Subject is male or female ≥ 65 years-old with a diagnosis of COPD (physician assessed). 2. 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). 3. Subject has oxygen therapy use within 3 months prior to study entry. 4. 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). 5. Subject is willing and able to attend study visits/telephone contacts and adhere to all study assessments/procedures. 6. 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.

Locations and Contacts

Study Manager, Phone: 1-866-503-6351

Birmingham VA Medical Center, Birmingham, Alabama 35233, United States; Recruiting
Study Coordinator, Phone: 205-399-8101

Clinical Trial Connection, Flagstaff, Arizona 86001, United States; Recruiting
Study Coordinator, Phone: 928-637-6614

Waterbury Pulmonary Associates LLC, Waterbury, Connecticut 06708, United States; Recruiting
Study Coordinator, Phone: 203-759-3656

George Washington University Medical Faculty Associates, Washington, District of Columbia 20037, United States; Recruiting
Study Coordinator, Phone: 202-741-3309

Southeastern Intergrted Medical, PL d/b/a Florida Medical Research, Gainesville, Florida 32607, United States; Recruiting
Study Coordinator, Phone: 352-333-8990

Miami VA Medical Center, Miami, Florida 33125, United States; Recruiting
Study Coordinator, Phone: 305-575-3412

Miami VA Medical Center, Miami, Florida 33125, United States; Recruiting
Study Coordinator, Phone: 305-575-7000

Gwinnett Biomedical Research, Lawrenceville, Georgia 30046, United States; Recruiting
Study Coordinator, Phone: 678-942-5986

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States; Recruiting
Study Coordinator, Phone: 402-559-8832

Clinical Research of Gastonia, Gastonia, North Carolina 28054, United States; Recruiting
Study Coordinator, Phone: 704-675-7144

Gastonia Phannaceutical Research, Gastonia, North Carolina 28054, United States; Recruiting
Study Coordinator, Phone: 704-867-8980

Clinical Research of Lake Norman, Huntersville, North Carolina 28078, United States; Recruiting
Study Coordinator, Phone: 704-659-9076

PMG Research of Wilmington, Wilmington, North Carolina 28401, United States; Recruiting
Study Coordinator, Phone: 910-133-5500

Southeastern Research Center, Winston-Salem, North Carolina 27103, United States; Recruiting
Study Coordinator, Phone: 336-659-8414

Cincinnati Veterans Affairs Medical Center, Cincinnati, Ohio 45220, United States; Recruiting
Study Coordinator, Phone: 513-861-3100

Remington-Davis, Inc., Columbus, Ohio 43215, United States; Recruiting
Study Coordinator, Phone: 614-487-2560

Consolidated Clinical Trials, Inc., Monroeville, Pennsylvania 15146, United States; Recruiting
Study Coordinator, Phone: 412-273-9100

Temple University Hospital, Temple Lung Center, Philadelphia, Pennsylvania 19140, United States; Recruiting
Study Coordinator, Phone: 215-707-8113

Upstate Pharmaceutical Research, Greenville, South Carolina 29615, United States; Recruiting
Study Coordinator, Phone: 864-255-3540

Clinical Research of Rock Hill, Rock Hill, South Carolina 29732, United States; Recruiting
Study Coordinator, Phone: 803-746-4541

S. Carolina Pharmaceutical Research, Spartanburg, South Carolina 29303, United States; Recruiting
Study Coordinator, Phone: 864-515-0092

Family Medicine Rural Health Clinic, PA, DBA FMC Science, Lampasas, Texas 76550, United States; Recruiting
Study Coordinator, Phone: 512-556-4130

Metroplex Pulmonary and Sleep Center, McKinney, Texas 75069, United States; Recruiting
Study Coordinator, Phone: 972-838-1892

Alamo Clinical Research Associates, San Antonio, Texas 78212, United States; Recruiting
Study Coordinator, Phone: 210-223-3010

Swedish Medical Center, Seattle, Washington 98122, United States; Recruiting
Study Coordinator, Phone: 206-215-3063

Additional Information

Starting date: November 2014
Last updated: July 27, 2015

Page last updated: August 23, 2015

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