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Chronic Obstructive Pulmonary DiseasePhase 3NCT00909779

Safety Study of Arformoterol Tartrate Inhalation Solution in Chronic Obstructive Pulmonary Disease (COPD) Subjects

A Phase 3 study testing Arformoterol in people with Chronic Obstructive Pulmonary Disease, run by Sumitomo Pharma America, Inc. at 73 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation will consist of a total of 6 visits over approximately 1 year. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Arformoterol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
841 participants
Where
73 sitesUnited States
Study dates
Jun 2009to Jun 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must give written informed consent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
  • Females considered not of childbearing potential must be surgically sterile (total hysterectomy, bilateral salpingo oophorectomy, or tubal ligation) or post-menopausal, which is defined as a complete cessation of menstruation for at least 1 year.
  • Male and female subjects must be at least 40 years old at the time of consent.
  • Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD.
  • Subjects must have a baseline FEV1 of ≤50% predicted volume at Visits 1 and 2 (pre-dose).
  • Subjects must have a FEV1 >0.50 L at either Visit 1 or 2 (pre-dose).
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  • Subject's respiratory status must be clinically stable.
  • Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤70% at either Visit 1 or 2 (pre-dose).
  • Subjects must have had at least 1 COPD exacerbation within the last year (defined as initiation or an increase in the dose of oral steroids or antibiotics for the treatment of COPD).
  • Subjects must have a ≥15 pack-year smoking history and a baseline breathlessness severity grade of ≥2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visit 2.
  • Female subjects ≤65 years of age must have a negative serum pregnancy test conducted at Visit 1 prior to randomization. Females of childbearing potential must be using an acceptable method of birth control.
  • Subjects' overall health must be sufficiently stable to complete the study requirements based on the screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis), and vital signs (heart rate, respiratory rate, and blood pressure) that have been conducted within 30 days of Visit 2 (randomization). If any of the hematology, chemistry, or urinalysis results are not within the laboratory's reference range, then the subject can be included only if the investigator judges the deviations to be not clinically significant.
  • Subjects must have a minimum blood pressure of 105/60 mmHg and a minimum resting pulse of 50 bpm at Screening Visit 1. Subjects who do not meet these criteria at Screening Visit 1 must meet the criteria on the first day of dosing (Day 1) in order to be eligible for the study. Subjects with a medical condition which causes low blood pressure or low heart rate, but, in the opinion of the Principal Investigator or designee the medical condition could resolve, may be rescreened when the condition is resolved.
  • Subjects must be willing and able to complete all study questionnaires and logs reliably.
  • Subjects must be willing and able to comply with study procedures and visit schedule.
  • Subjects must have sufficient understanding of English to complete all questionnaires and logs.

Who cannot join

  • Female subjects who are pregnant or lactating.
  • Subjects with a history of asthma, with the exception of asthma diagnosed in childhood.
  • Subjects with a blood eosinophil count >5% of total white blood cell count.
  • Subjects with a febrile illness within 3 days before Screening.
  • Subjects with a malignant neoplasm other than non melanomatous basal cell skin cancer. Subjects with a history of malignancy who have been cancer free for 5 years or more may be enrolled.
  • Subjects who are currently using disallowed medications or will be unable to complete the medication washout periods. Subjects taking a prohibited concurrent medication which requires a washout of >30 days may be rescreened when the washout of the prohibited concurrent medication has been met.
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  • Subjects with life threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to screening.
  • Subjects who have had a change in dose or type of any medications for COPD within 2 weeks prior to the screening visit. Subjects not on a stable dose of COPD medications may be rescreened after being on a stable dose for at least 14 days
  • Subjects with a chest x ray taken ≤3 months prior to screening that suggests a diagnosis other than COPD (eg, diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions). If there is no chest x ray taken ≤3 months prior to screening, or if recent results are unavailable for review, a chest x ray must be performed prior to visit 2. Subjects with a medical condition that caused the abnormal finding, but, in the opinion of the Principal Investigator or designee the medical condition could resolve, may be rescreened when the condition is resolved
  • Subjects with a positive urine drug test during screening.
  • Subjects with a known history of alcohol abuse may be enrolled in the study if the subject's current alcohol use does not exceed more than 3 alcoholic beverages per day.
  • Subjects whose schedule or travel prevents the completion of all required visits.
  • Subjects who are scheduled for inpatient hospitalization or elective surgery (inpatient or outpatient) during the trial. Subjects may be rescreened when the condition is resolved.
  • Subjects have participated in an investigational drug study and/or any COPD interventional trial within 30 days prior to screening or who are currently participating in another investigational drug study or COPD interventional trial.
  • Subjects with a history of allergic reaction to the study medication or any components of the study medications.
  • Subjects who are study site staff members or relatives of study site staff members directly involved in this study.
  • Subjects with clinically significant cardiac, (Functional Class III and IV; Objective Class C and D by New York Heart Association [NYHA] Functional Classification),hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol.

Trial locations and contacts

73 sites in 1 country.

73 sites in 1 country

United States73 sites

  • DayStar Clinical Research, Inc.

    Akron, Ohio, 44313

  • Chest Critical Care Consultants

    Anaheim, California, 92801

  • ClinSite LLC

    Ann Arbor, Michigan, 48106

  • DCT

    Arlington, Texas, 76014

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Jefferson Clinic

    Birmingham, Alabama, 25233

  • Alabama Clinical Therapeutic, LLC

    Birmingham, Alabama, 35235

  • Achieve Clinical Research

    Brimingham, Alabama, 35209

  • Study site

    Canton, Georgia, 30114

  • Lowcountry Lung & Critical Care, PA

    Charleston, South Carolina, 29406

  • American Health Research Inc.

    Charlotte, North Carolina, 28207

  • Charlottesville Medical Research Inc.

    Charlottesville, Virginia, 22911

  • Delaware Valley Clinical Research

    Cherry Hill, New Jersey, 08003

  • Southeast Clinical Research

    Chiefland, Florida, 32626

  • Bernstein Clinical Research Center

    Cincinnati, Ohio, 45231

  • Tampa Bay Medical Research Inc.

    Clearwater, Florida, 33761

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Neem Research Group, Inc.

    Columbia, South Carolina, 29201

  • Southeast Regional Research Group

    Columbus, Georgia, 31904

  • Atlanta Pharmaceutical Research

    Decatur, Georgia, 30033

  • Avail Clinical Research

    DeLand, Florida, 32720

  • National Jewish Health

    Denver, Colorado, 80206

  • Medisphere Medical Research Center

    Evansville, Indiana, 47714

  • California Research Medical Group

    Fullerton, California, 92835

  • Gaffney Pharmaceutical Research

    Gaffney, South Carolina, 29340

  • Greenville Pharmaceutical Research

    Greenville, South Carolina, 29615

  • Upstate Pharmaceutical Research

    Greenville, South Carolina, 29615

  • Mountain View Clinical Research, Inc.

    Greer, South Carolina, 29651

  • Kentucky Lung Clinic

    Hazard, Kentucky, 41701

  • Baylor College of Medicine, Clinical Studies Unit, Ben Taub General Hospital

    Houston, Texas, 77030

  • VAMC

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Jasper Summit Research, LLC

    Jasper, Alabama, 35501

  • Kingwood Research Institute, LLC

    Kingwood, Texas, 77339

  • The Lung Clinic, P.A.

    Kissimmee, Florida, 34741

  • Allergy Associates

    Knoxville, Tennessee, 37909

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Bendel Medical Research Center, LLC

    Lafayette, Louisiana, 70503

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Wellstar Marietta Pulmonary Medicine

    Marietta, Georgia, 30060

  • Clinical Research Institute of Southern Oregon, PC

    Medford, Oregon, 97504

  • Clinical Research Institute Inc.

    Minneapolis, Minnesota, 55402

  • New York Pulmonary and Clinical Care Associates, PC

    New York, New York, 10016

  • ENT & Allergy Associates

    Newburgh, New York, 12550

  • DCT

    Orlando, Florida, 32806

  • Biomedical Research Alliance at Hypertension and Nephrology

    Pawtucket, Rhode Island, 02860

  • Arcuri Clinical Research, LLC

    Philadelphia, Pennsylvania, 19142

  • Allergy Associates Research Center

    Portland, Oregon, 97216

  • National Clinical Resources, Inc.

    Provo, Utah, 84604

  • Dominion Medical Associates

    Richmond, Virginia, 23219

  • Pulmonary Associates of Richmond Inc.

    Richmond, Virginia, 23225

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23229

  • Southeast Regional Research Group

    Rincon, Georgia, 31326

  • Integrated Research Group

    Riverside, California, 92506

  • Rochester Clinical Research

    Rochester, New York, 14609

  • AAIR Research Center

    Rochester, New York, 14618

  • Quality Control Research Inc.

    Roseville, California, 95661

  • Sockolov and Sockolov APC

    Sacramento, California, 95825

  • Centers for Clinical Trials of Sacremento

    Sacremento, California, 95823

  • Midwest Chest Consultants

    Saint Charles, Missouri, 63301

  • Utah Clinical Trials LLC

    Salt Lake City, Utah, 84107

  • Physician PrimeCare Research

    San Antonio, Texas, 78212

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • Institute of HealthCare Assessment, Inc.

    San Diego, California, 92120

  • S. Carolina Pharmaceutical Research

    Spartanburg, South Carolina, 29303

  • C.A.R.E. Clinical Research

    St Louis, Missouri, 63141

  • DCT

    Sugar Land, Texas, 77878

  • Pulmonary Consultants, PLLC

    Tacoma, Washington, 98405

  • Clinical Research of West Florida

    Tampa, Florida, 33603

  • CU Pharmaceutical Research

    Union, South Carolina, 29379

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • SouthEast Research Institute

    Webster, Texas, 77598

  • Piedmont Medical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Large Simple Safety Study of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation will consist of a total of 6 visits over approximately 1 year.

Read the detailed description

This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group, outpatient, safety study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. The administration of arformoterol in subjects with moderate to severe COPD will not result in a meaningfully greater incidence of respiratory death and COPD exacerbation -related hospitalizations compared to placebo (nebulized saline and non-long-acting beta2-agonist [LABA] COPD standard of care treatments). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Being tested
Arformoterol, Placebo
Keywords
Chronic obstructive pulmonary disease (COPD), respiratory, long-acting beta agonist (LABA)
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ArformoterolDrug

    Also called Brovana

    Arformoterol Tartrate Inhalation Solution 15 mcg twice daily (BID) for a duration of one year

  • PlaceboDrug

    Placebo inhalation solution, twice daily (BID) for a duration of one year.

Study groups in NCT00909779
Study groupRoleWhat they receive
Arformoterol 15 mcg twice dailyExperimentalArformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
Receives: Drug: Arformoterol
Placebo twice dailyPlacebo comparatorPlacebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time From Randomization to Respiratory Death or First COPD Exacerbation Related Hospitalization (Whichever Occurs First).

    COPD exacerbation: an increase in COPD symptoms that necessitated any change in baseline medication (bronchodilators,anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc.).Hospitalization: any inpatient admission or any emergency department visit > 24 hours in duration. Hospice was considered hospitalization.COPD exacerbation related hospitalization: hospitalization that was due to 1) COPD exacerbation or 2) a COPD exacerbation preceded, or occurred concomitantly with the onset of, the event for which the subject was hospitalized.Respiratory-related death: For each death the Primary Investigator designated a 'probable cause', which was the primary condition that precipitated the terminal events that were the immediate cause of death. If a probable cause could not be ascertained, the cause of death was considered 'UNKNOWN'. Cause other than 'UNKNOWN' was categorized as either respiratory or non-respiratory. Deaths of 'UNKNOWN' cause were counted as primary events.

    Measured: 0-12 months

Secondary outcomes (8)

  1. The Incidence of Protocol Defined COPD Exacerbations.

    A protocol-defined exacerbation of COPD was defined as an increase in respiratory symptoms (classically, increased shortness of breath, increased sputum production, and/or increased sputum purulence) that necessitates any change in baseline medication other than bronchodilators (e.g., anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc) or causes the subject to require additional medical attention (i.e., emergency room visit or hospitalization).

    Measured: 0-12 months

  2. The Incidence of All Cause Mortality

    Survival status at the end of the study will be determined for each subject. The proportion of subjects dead and the annual event rate will be summarized by treatment.

    Measured: 0-12 months

  3. The Incidence of Treatment Emergent AEs

    TEAEs were defined as: 1) adverse events that occurred on or after the date of first dose of study medication, 2) adverse events with a missing start date and a stop date on or after the date of first does of study medication, or 3) adverse events with both a missing start and stop date.

    The frequency and percentage of subjects with TEAEs were summarized. At each level of summarization, a subject was counted only once for each AE he/she experienced within that level. The percentage of subjects having had at least 1 AE at each level was calculated.

    Measured: 0-12 months

  4. SGRQ: Mean Change From Baseline in Total Score

    The SGRQ assessed health status and consisted of 3 component scores (Symptoms, Activity, and Impacts) as well as a total score. Items were scored in accordance with the developer's guidelines. Scores were expressed as a percentage of overall impairment, where 100 represented worst possible health status and 0 indicated best possible health status. The SGRQ was assessed pre-dose at baseline, months 3, 6 and 12 or the end of study (EOS). Visit 2 was defined as baseline. A change from baseline in the Total Score of ≥ 4 units is considered the minimal clinically important difference (MCID) for SGRQ.

    Measured: Baseline and on treatment at months 3, 6 and 12 (or early termination)

  5. FEV1: Mean Change From Baseline

    FEV1 was measured at Visit 1 (screening), pre- and post-albuterol administration for reversibility testing, pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FEV1 from at least 3 acceptable maneuvers was recorded. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last FEV1 value obtained prior to first treatment was used for baseline.

    Measured: Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)

  6. Percent Predicted FEV1: Mean Change From Baseline

    Percent predicted FEV1: measured FEV1 as a percent of the "predicted values" for the patients of similar characteristics (height, age, sex, and sometimes race and weight). Best FEV1 percent predicted was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS, as described for FEV1.

    Measured: Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)

  7. Forced Vital Capacity (FVC): Mean Change From Baseline

    Forced Vital capacity: the volume of air that can forcibly be blown out after full inspiration. Best FVC was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FVC from at least 3 acceptable maneuvers was recorded.

    Measured: Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)

  8. Inspiratory Capacity (IC): Mean Change From Baseline

    IC: the total amount of air that can be drawn into the lungs after normal expiration.

    IC was measured pre- and post-albuterol administration at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. IC maneuvers were done in triplicate. The mean of all recorded IC values was used for each subject at each time point. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last IC value obtained prior to first treatment dose was used for baseline.

    Measured: Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
841 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00909779
Sponsor's protocol ID
091-080
Status last verified
Sep 2013
First submitted
26 May 2009
Last updated
11 Nov 2013
Data monitoring committee
Yes

Publications

  • Donohue JF, Ganapathy V, Bollu V, Stensland MD, Nelson LM. Health Status of Patients with Moderate to Severe COPD after Treatment with Nebulized Arformoterol Tartrate or Placebo for 1 Year. Clin Ther. 2017 Jan;39(1):66-74. doi: 10.1016/j.clinthera.2016.11.021. Epub 2016 Dec 20.

    PubMed 28011247

  • Donohue JF, Hanania NA, Make B, Miles MC, Mahler DA, Curry L, Tosiello R, Wheeler A, Tashkin DP. One-year safety and efficacy study of arformoterol tartrate in patients with moderate to severe COPD. Chest. 2014 Dec;146(6):1531-1542. doi: 10.1378/chest.14-0117.

    PubMed 25451347

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Arformoterol in people with Chronic Obstructive Pulmonary Disease, run by Sumitomo Pharma America, Inc. at 73 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomization to Respiratory Death or First COPD Exacerbation Related Hospitalization (Whichever Occurs First). (time frame: 0-12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00909779, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.

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