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TerminatedNCT02275481Updated Jun 27, 2018Results posted

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

A Phase 4 interventional study of Arformoterol tartrate inhalation solution and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Sumitomo Pharma America, Inc.. Terminated at 28 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2018-06-27.

Sponsored by Sumitomo Pharma America, Inc. · Phase 4, Interventional, and Treatment

Why this study was terminated
lack of enrollment
Phase
Phase 4
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)

Keywords

  • Chronic obstructive pulmonary disease
  • COPD
  • Emphysema
  • Chronic bronchitis
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In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 66 is close to the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • 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

  • Active comparator
    SPIRIVA

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

    Drug: Tiotropium

Interventions

  • DrugArformoterol 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

    Also known as: BROVANA

  • DrugTiotropium

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

    Also known as: SPIRIVA

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 90 days

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Results

Posted Oct 2, 2017
Limitations and caveats
study was terminated early due to lack of enrollment

Participant flow

Before recruitment and enrollment, each prospective subject was given a full explanation of the study, allowed to read the approved informed consent form and was provided ample time and the opportunity to ask any questions that may have arose.

Participant flow — Overall Study
MilestoneBROVANASPIRIVA
Started3234
Completed2331
Not completed93
Withdrew: Death21
Withdrew: Lost to follow-up20
Withdrew: Withdrawal by subject30
Withdrew: All other reasons combined21
Withdrew: Physician decision01

Outcome measures

PrimaryNumber 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.

Time frame:
Up to 90 days

No measurements were reported for this outcome.

Adverse events

Collected over The AE reporting period lasts ~ 19 months. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BROVANA2/32 (6.3%)15/32 (46.9%)19/32 (59.4%)
SPIRIVA1/34 (2.9%)13/34 (38.2%)23/34 (67.6%)
Most frequent serious events
Showing 10 of 31
Most frequent serious events
EventBROVANASPIRIVA
chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders10/3210/34
pneumoniaInfections and infestations6/320/34
respiratory failureRespiratory, thoracic and mediastinal disorders3/322/34
abdominal painGastrointestinal disorders0/322/34
hypoglycaemiaMetabolism and nutrition disorders0/322/34
atrial fibrillationCardiac disorders1/320/34
cardiac failureCardiac disorders1/320/34
supraventricular tachycardiaCardiac disorders1/320/34
acute sinusitisInfections and infestations1/320/34
clostridium difficile colitisInfections and infestations1/320/34
Most frequent other events
Showing 10 of 88
Most frequent other events
EventBROVANASPIRIVA
chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders9/328/34
dyspnoeaRespiratory, thoracic and mediastinal disorders1/326/34
consitpationGastrointestinal disorders1/324/34
hyperglycaemiaMetabolism and nutrition disorders2/324/34
wheezingRespiratory, thoracic and mediastinal disorders0/324/34
diarrhoeaGastrointestinal disorders3/321/34
fatigueGeneral disorders0/323/34
contusionInjury, poisoning and procedural complications0/323/34
fallInjury, poisoning and procedural complications1/323/34
headacheNervous system disorders2/323/34

Baseline characteristics

full analysis set

Age, Categorical
Age, Categorical(Participants)BROVANASPIRIVATotal
<=18 years000
Between 18 and 65 years257
>=65 years302959
Age, Continuous
Age, Continuous(years)BROVANASPIRIVATotal
Mean71.9 ± 6.8672.1 ± 6.6572.0 ± 6.70
Sex: Female, Male
Sex: Female, Male(Participants)BROVANASPIRIVATotal
Female181634
Male141832
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BROVANASPIRIVATotal
Hispanic or Latino000
Not Hispanic or Latino323466
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BROVANASPIRIVATotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American6713
White262753
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)BROVANASPIRIVATotal
United States323466
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Study locations

28 sites
  • Birmingham VA Medical Center
    Birmingham, Alabama 35233, United States
  • Clinical Trial Connection
    Flagstaff, Arizona 86001, United States
  • Waterbury Pulmonary Associates LLC
    Waterbury, Connecticut 06708, United States
  • George Washington University Medical Faculty Associates
    Washington, District of Columbia 20037, United States
  • Southeastern Intergrted Medical, PL d/b/a Florida Medical Research
    Gainesville, Florida 32607, United States
  • Miami VA Medical Center
    Miami, Florida 33125, United States
  • Gwinnett Biomedical Research
    Lawrenceville, Georgia 30046, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • VA Western New York Healthcare System
    Buffalo, New York 14215, United States
  • Clinical Research of Gastonia
    Gastonia, North Carolina 28054, United States
  • Gastonia Phannaceutical Research
    Gastonia, North Carolina 28054, United States
  • Clinical Research of Lake Norman
    Huntersville, North Carolina 28078, United States
  • PMG Research of Wilmington
    Wilmington, North Carolina 28401, United States
  • Southeastern Research Center
    Winston-Salem, North Carolina 27103, United States
  • Cincinnati Veterans Affairs Medical Center
    Cincinnati, Ohio 45220, United States
  • Remington-Davis, Inc.
    Columbus, Ohio 43215, United States
  • Consolidated Clinical Trials, Inc.
    Monroeville, Pennsylvania 15146, United States
  • Temple University Hospital, Temple Lung Center
    Philadelphia, Pennsylvania 19140, United States
  • Upstate Pharmaceutical Research
    Greenville, South Carolina 29615, United States
  • Clinical Research of Rock Hill
    Rock Hill, South Carolina 29732, United States
  • S. Carolina Pharmaceutical Research
    Spartanburg, South Carolina 29303, United States
  • Mid State Pulmonary
    Nashville, Tennessee 37203, United States
  • Family Medicine Rural Health Clinic, PA, DBA FMC Science
    Lampasas, Texas 76550, United States
  • Metroplex Pulmonary and Sleep Center
    McKinney, Texas 75069, United States
  • Alamo Clinical Research Associates
    San Antonio, Texas 78212, United States
  • Swedish Medical Center
    Seattle, Washington 98122, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02275481
Lead sponsor
Sumitomo Pharma America, Inc.
Responsible party
Sponsor
First posted
Oct 27, 2014
Start date
Nov 2014
Primary completion
Sep 14, 2016
Completion
Sep 14, 2016
Results posted
Oct 2, 2017
Last update
Jun 27, 2018

Study contacts

Respiratory Medical Director, MD
study director · Sumitomo Pharma America, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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