Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT02275481
A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects
A Phase 4 study testing Arformoterol tartrate inhalation solution and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by Sumitomo Pharma America, Inc. at 28 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Arformoterol tartrate inhalation solution and Tiotropium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 28 sitesUnited States
- Study dates
- Nov 2014to 14 Sep 2016
- Phase
- Phase 4
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
- Subject has had oxygen therapy use within 3 months prior to study entry.
- 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).
- Subject is willing and able to attend study visits/telephone contacts and adhere to all study assessments/procedures.
- Subject is willing and able to provide written informed consent.
Who cannot join
- 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.
- Subject has a primary diagnosis of asthma.
- Subject has a history of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
- Subject has a history of urinary retention or bladder neck obstruction type symptoms.
- Subject has a history of narrow angle glaucoma.
- Subject has a recent history (previous 12 months) of excessive use or abuse of alcohol or narcotic/illegal drugs, as assessed by the Investigator.
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- Subject has a history of hypersensitivity or intolerance to aerosol medications, beta-2 agonists, or anticholinergics.
- 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.
- Subject is a staff member of the clinical site or a relative of a clinical site staff member.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Birmingham VA Medical Center
Birmingham, Alabama, 35233
Brigham and Women's Hospital
Boston, Massachusetts, 02115
VA Western New York Healthcare System
Buffalo, New York, 14215
Cincinnati Veterans Affairs Medical Center
Cincinnati, Ohio, 45220
Remington-Davis, Inc.
Columbus, Ohio, 43215
Clinical Trial Connection
Flagstaff, Arizona, 86001
Southeastern Intergrted Medical, PL d/b/a Florida Medical Research
Gainesville, Florida, 32607
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
Gastonia Phannaceutical Research
Gastonia, North Carolina, 28054
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615
Clinical Research of Lake Norman
Huntersville, North Carolina, 28078
Family Medicine Rural Health Clinic, PA, DBA FMC Science
Lampasas, Texas, 76550
Gwinnett Biomedical Research
Lawrenceville, Georgia, 30046
Metroplex Pulmonary and Sleep Center
McKinney, Texas, 75069
Miami VA Medical Center
Miami, Florida, 33125
Consolidated Clinical Trials, Inc.
Monroeville, Pennsylvania, 15146
Mid State Pulmonary
Nashville, Tennessee, 37203
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Temple University Hospital, Temple Lung Center
Philadelphia, Pennsylvania, 19140
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Alamo Clinical Research Associates
San Antonio, Texas, 78212
Swedish Medical Center
Seattle, Washington, 98122
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, 29303
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Waterbury Pulmonary Associates LLC
Waterbury, Connecticut, 06708
PMG Research of Wilmington
Wilmington, North Carolina, 28401
Southeastern Research Center
Winston-Salem, North Carolina, 27103
About this study
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
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.
- Being tested
- Arformoterol tartrate inhalation solution, Tiotropium
- Keywords
- Chronic obstructive pulmonary disease, COPD, Emphysema, Chronic bronchitis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arformoterol tartrate inhalation solutionDrug
Also called 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
TiotropiumDrug
Also called SPIRIVA
Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
| Study group | Role | What they receive |
|---|---|---|
| BROVANA | Experimental | 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 Receives: Drug: Arformoterol tartrate inhalation solution |
| SPIRIVA | Active comparator | Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®. Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startNov 2014
- Primary completion14 Sep 2016
- Study completion14 Sep 2016
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Respiratory Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275481
- Sponsor's protocol ID
- SEP091-402
- Status last verified
- Jun 2018
- First submitted
- 23 Oct 2014
- Last updated
- 27 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02275481
- Acronym / sponsor ID
- SEP091-402
- Keywords
- Chronic obstructive pulmonary disease, COPD, Emphysema, Chronic bronchitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- 14 Sep 2016 (actual)
- Study completion
- 14 Sep 2016 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Posted 2 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BROVANA | Experimental | Drug: Arformoterol tartrate inhalation solutionArformoterol 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 |
| SPIRIVA | Active comparator | Drug: TiotropiumTiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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).
- Subject is willing and able to attend study visits/telephone contacts and adhere to all study assessments/procedures.
- Subject is willing and able to provide written informed consent.
Key exclusion criteria (9 listed)
- 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.
- Subject has a primary diagnosis of asthma.
- Subject has a history of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
- Subject has a history of urinary retention or bladder neck obstruction type symptoms.
- Subject has a history of narrow angle glaucoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arformoterol tartrate inhalation solutionAlso: BROVANAArformoterol 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 | BROVANA |
| TiotropiumAlso: SPIRIVATiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®. | Drug | SPIRIVA |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Respiratory Medical Director, MD study director
Sumitomo Pharma America, Inc.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arformoterol tartrate inhalation solution and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by Sumitomo Pharma America, Inc. at 28 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 2 Oct 2017). 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?
Number of Participants Experiencing All-cause Hospitalization or Emergency Department Visit Within 90-days of Initiating Treatment (time frame: Up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2018.