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

This study has been terminated.
(lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02275481
First Posted: October 27, 2014
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunovion
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Arformoterol tartrate inhalation solution Drug: Tiotropium Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Number of Participants Experiencing All-cause Hospitalization or Emergency Department Visit Within 90-days of Initiating Treatment [ Time Frame: Up to 90 days ]
    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.


Enrollment: 66
Actual Study Start Date: November 2014
Study Completion Date: September 14, 2016
Primary Completion Date: September 14, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Other Name: BROVANA
Active Comparator: SPIRIVA
Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Drug: Tiotropium
Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Other Name: SPIRIVA

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275481


  Show 28 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Respiratory Medical Director, MD Sunovion
  More Information

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT02275481     History of Changes
Other Study ID Numbers: SEP091-402
First Submitted: October 23, 2014
First Posted: October 27, 2014
Results First Submitted: September 5, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Sunovion:
Chronic obstructive pulmonary disease
COPD
Emphysema
Chronic bronchitis

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Pharmaceutical Solutions
Tiotropium Bromide
Formoterol Fumarate
Bromides
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents