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Chronic Obstructive Pulmonary Disease (COPD)Phase 3GOLDEN-5NCT02276222

A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD

A Phase 3 study testing SUN-101 50 mcg BID eFlow (CS) nebulizer and Spiriva® 18 mcg QD Handihaler in people with Chronic Obstructive Pulmonary Disease (COPD), run by Sunovion Respiratory Development Inc. at 118 sites in 4 countries.

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 long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week, open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a day or Spiriva® [tiotropium] given as 18 mcg once a day). Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
SUN-101 50 mcg BID eFlow (CS) nebulizer and Spiriva® 18 mcg QD Handihaler
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,087 participants
Where
118 sitesin 4 countries
Study dates
Oct 2014to Feb 2016
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

  • Male or female patients age ≥ 40 years, inclusive.
  • A clinical diagnosis of COPD according to the GOLD 2014 guidelines.
  • Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
  • Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 < 80% of predicted normal and > 0.7 L during Screening (Visit 1).
  • Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio < 0.70 during Screening (Visit 1).
  • Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).
Show all 9Show fewer
  • Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at Visit 1. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: a) an oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following participation; b) barrier method of contraception, e.g., condom and /or diaphragm with spermicide while participating in the study; and/or c) abstinence..
  • Willing and able to provide written informed consent.
  • Willing and able to attend all study visits and adhere to all study assessments and procedures.

Who cannot join

  • Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject.
  • Concomitant clinically significant respiratory disease other than COPD (eg, asthma, tuberculosis, bronchiectasis or other non-specific pulmonary disease).
  • Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening (Visit 1).
  • Use of daily oxygen therapy > 12 hours per day.
  • Respiratory tract infection within 6 weeks prior to Screening (Visit 1).
  • Use of systemic steroids within 3 months prior to Screening (Visit 1).
Show all 16Show fewer
  • History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin.
  • Prolonged QTc (> 450 msec for males and > 470 msec for females) during Screening (Visit 1), or history of long QT syndrome.
  • History of or clinically significant ongoing bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months.
  • History of narrow angle glaucoma.
  • History of hypersensitivity or intolerance to aerosol medications.
  • Recent documented history (within the previous 3 months) of substance abuse.
  • Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator.
  • Participation in another investigational drug study where drug was received within 30 days prior to Screening (Visit 1) or current participation in another investigational drug trial, including a SUN-101 study.
  • Previously received SUN-101 (active treatment; formerly known as EP-101).
  • Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines.

Trial locations and contacts

118 sites in 4 countries.

118 sites in 4 countries

United States83 sites

  • SEC Lung LLC

    Andalusia, Alabama, 36420

  • Achieve Clinical Research LLC

    Birmingham, Alabama, 35216

  • Tampa Bay Clinical Research Center

    Brandon, Florida, 33511

  • Cadillac Clinical Research LLC

    Cadillac, Michigan, 49601

  • Clinical Research Advantage, Inc.lEast Valley Family Physicians, PLC

    Chandler, Arizona, 85224

  • Lowcountry Lung and Critical Care, PA

    Charleston, South Carolina, 29406

  • American Health Research, Inc.

    Charlotte, North Carolina, 28207

  • IVA Researcb

    Cincinnati, Ohio, 45245

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • H.C. Research LLC

    Coeur d'Alene, Idaho, 83814

  • Howard County Center for Lung and Sleep Medicine, LLC

    Columbia, Maryland, 21044

  • Remington Davis Inc

    Columbus, Ohio, 43215

  • Corsicana Medical Research, PLLC

    Corsicana, Texas, 75110

  • Avail Clinical Research, llC

    DeLand, Florida, 32720

  • Easley Clinical Research

    Easley, South Carolina, 29640

  • Palmetto Medical Research Associates

    Easley, South Carolina, 29640

  • Minnesota Lung Center

    Edina, Minnesota, 55435

  • Evanston Premier Healthcare Research LLC

    Evanston, Illinois, 60201

  • Lillestol Research, LLC

    Fargo, North Dakota, 58103

  • Abraham Research, PLLC

    Fort Mitchell, Kentucky, 41017

  • Allianz Research Institute, Inc.

    Fountain Valley, California, 92708

  • Research Center of Fresno, Inc.

    Fresno, California, 93702

  • California Research Medical Group, lnc.

    Fullerton, California, 92835

  • Gaffney Pharmaceutical Research

    Gaffney, South Carolina, 29340

  • Spectrum Medical Research, LLC

    Gaffney, South Carolina, 29341

  • Greenville Pharmaceutical Research, Inc.

    Greenville, South Carolina, 29615

  • Upstate Pharmaceutical Research, Inc.

    Greenville, South Carolina, 29615

  • DeGarmo Institute of Medical Research

    Greer, South Carolina, 29651

  • Kentucky Lung Clinics, PSC

    Hazard, Kentucky, 41701

  • The Community Research of South Florida

    Hialeah, Florida, 33016

  • Pioneer Research Solutions, Inc

    Houston, Texas, 77099

  • ARSM Research

    Huntersville, North Carolina, 28078

  • Clinical Research of Lake Norman

    Huntersville, North Carolina, 28078

  • ISA Clinical Research

    Jamaica, New York, 11435

  • Jasper Summit Research LLC

    Jasper, Alabama, 35501

  • New Phase Clinical Research & Development

    Knoxville, Tennessee, 37919

  • Bendel Medical Research Center, LLC

    Lafayette, Louisiana, 70508

  • Clinical Research Advantage Inc

    Las Vegas, Nevada, 89128

  • Gwinnett Biomedical Research

    Lawrenceville, Georgia, 30046

  • Somnos Laboratories, Inc d/b/a Somnos Clinical Research

    Lincoln, Nebraska, 68510

  • Pulmonary Research Institute of Southeast Michigan

    Livonia, Michigan, 48152

  • Southern California Institute For Respiratory Diseases, Inc.

    Los Angeles, California, 90048

  • Delaware Valley Clinical Research, LLC

    Marlton, New Jersey, 08053

  • Clinical Research Institute of Southern Oregon, PC

    Medford, Oregon, 97504

  • Sunstone Medical Research, L.LC

    Medford, Oregon, 97504

  • AppleMed Research, Inc

    Miami, Florida, 33155

  • Research Institute of South Florida, Inc

    Miami, Florida, 33173

  • Clinical Trials of Florida, LLC

    Miami, Florida, 33186

  • LaPorte County Institute For Clinical Research

    Michigan City, Indiana, 46360

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402

  • Minnesota Lung Center

    Minneapolis, Minnesota, 55407

  • Clinical Research of Charleston

    Mt. Pleasant, South Carolina, 29464

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Atlantic Research Center, LLC

    Ocean City, New Jersey, 07712

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Florida Institute For Clinical Research, LLC

    Orlando, Florida, 32825

  • Ribo Research, LLC dba Peninsula Research, Inc.

    Ormond Beach, Florida, 32174

  • Allergy Associates Research Center

    Portland, Oregon, 97202

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • Asthma and Allergy Center of Chicago SC

    River Forest, Illinois, 60305

  • Integrated Research Group, Inc

    Riverside, California, 92506

  • Midwest Chest Consultants PC

    Saint Charles, Missouri, 63301

  • Alamo Clinical Research Associates

    San Antonio, Texas, 78212

  • Institute of Healthcare Assessments Inc.

    San Diego, California, 92120

  • Hope Clinical Research

    Seneca, South Carolina, 29678

  • S. Carolina Pharmaceutical Research

    Spartanburg, South Carolina, 29303

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • CARE Clinical Research

    St Louis, Missouri, 63141

  • Midwest Clinical Research LLC

    St Louis, Missouri, 63141

  • The Clinical Research Center

    St Louis, Missouri, 63141

  • Pulmonary and Allergy Associates, PA

    Summit, New Jersey, 07901

  • Pulmonary Consultants PLLC

    Tacoma, Washington, 98405

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603

  • Clinical Research of West Florida

    Tampa, Florida, 33603

  • Pulmonary and Critical Care Associates of Baltimore

    Towson, Maryland, 21204

  • Desert Sun Clinical Research LLC

    Tucson, Arizona, 85710

  • CU Pharmaceutical Research

    Union, South Carolina, 29379

  • Buynak Clinical Research, P.C.

    Valparaiso, Indiana, 46383

  • Vero Lung Center

    Vero Beach, Florida, 32960

  • Waterbury Pulmonary Associates, LLC

    Waterbury, Connecticut, 06708

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

  • Minnesota Lung Center

    Woodbury, Minnesota, 55125

Other trials in United States

Russia14 sites

  • Territorial SBI of Healthcare <Territorial Clinical Hospital>

    Barnaul, 656024

  • FSBI Far Eastern Research Centre ofPhysiology and Pathology of Breathing of Siberian branch of RAMS

    Blagoveshchensk, 675000

  • SBI of Healthcare Regional Clinical Hospital #4 City consultative department for pulmonological patientsr

    Chelyabinsk, 454021

  • Municipal Budget Institution of Healthcare (City Clinical Hospital #3 n.a. M.A. Podgorbunsky)

    Kemerovo, 650000,

  • FSSI Scientific Research Institute of Complex Cardiovascular Pathology

    Kemerovo, 650002

  • FSBI

    Moscow, 115682

  • Non-State Private Institution of Healthcare <Scientific Clinical Center>

    Moscow, 125315

  • SBI of Healthcare of Nizhny-Novgorod region

    Nizhny Novgorod, 603126

  • SB1 of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>l

    Novosibirsk, 630087

  • SBI of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>

    Novosibirsk, 630087

  • Alliance Biomedical, Russian Group LLC

    Saint Petersburg, 194358

  • SBEI of HPE <North-West State Medical University n.a. LL Mechnikov>

    Saint Petersburg, 195067

  • SBr of Helathcareof Yaraslavl region Clinical Hospital of Emervency care n.a.N.V. Solovyev

    Yaroslavl, 150003

  • Municipal Autonomous Institution (City ClinicalHospital #14)

    Yekaterinburg, 620039

Other trials in Russia

Hungary12 sites

  • Dr. Kenessey Albert Korhaz-Rendetointezet, TOd6gy6gyaszati

    Balassagyarmat, H-2660

  • Csornai Margit Korhaz, TOd6gy6gyaszat

    Csorna, H-9300

  • Kenezy Gyula Korhaz es Rendelomtezet, Klinikai Farmakologiai

    Debrecen, H-4043

  • Veszprern Megyei Tudbgyogyintezet

    Farkasgyepű, H-8582

  • Somogy Megyei Kaposi M6r Oktat6 Korhaz, Tudoqondozo

    Kaposvár, H-7400

  • Lumniczer Sandor Korhaz as Rendelointezet, Tudoqondozo

    Kapuvár, H-9330

  • Selye Janos Korhaz es Rendelointezet, Tud6gy6gyaszati Szakrendeles

    Komárom, H-2900

  • Szakorvosi Rendelointezet Monor, Tudoqondozo

    Monor, H-2200

  • Revamed Eqeszsequqyi Szolqaltato Kft.

    Nyíregyháza, H-4400

  • Si6fok Kornaz-Rendelointezet, Tudoqondozo

    Siófok, H-8600

  • Farmakontroll Egeszsegugyi Szolqaltato Bt

    Százhalombatta, H-2440

  • Csonqrad Megyei Mellkasi Beteqseqek Szakkorhaza, Tudoqondozo lntezet

    Szeged, H-6722

Other trials in Hungary

Czechia9 sites

  • Medicentrum Beroun s.r o.

    Beroun, 266 01

  • MediTrial, s.r.o Internf a pneumoloqicka ambulance

    Jindřichův Hradec, 377 01

  • Nemocnice Kyjov, p.o.

    Kyjov, 69733

  • Plicni ambulance

    Neratovice, 277 11

  • MephaCentrum, a s Plicni oddeleni

    Ostrava - Poruba, 708 00

  • MephaCentrum, a.s.

    Ostrava-Poruba, 708 00

  • PNEUMa-HOST s LO.

    Prague, 158 00

  • PLiCNI AMBULANCE ROKYCANY, s.r o.

    Rokycany, 337 01

  • Hrudnf ambulance s.r.o.

    Žatec, 438 01

Other trials in Czechia

About this study

Official title: A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter, Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-5 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week, open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a day or Spiriva® [tiotropium] given as 18 mcg once a day).

Read the detailed description

This is a Phase 3, randomized, open-label, active-controlled, parallel-group, multicenter, long-term safety trial of 48 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer or Spiriva in approximately 1050 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.

Eligible subjects will enter the 48-week, open-label treatment period following randomization to receive one of two treatments (SUN-101 given as 50 mcg BID or Spiriva® [tiotropium] given as 18 mcg QD).

The hypothesis for this study is that the incidence of treatment-emergent adverse events reported over the course of 48 weeks of treatment by subjects randomized to SUN-101 is numerically similar to the incidence of treatment-emergent adverse events reported over the course of 48 weeks of treatment by subject randomized to Spiriva (tiotropium).

Being tested
SUN-101 50 mcg BID eFlow (CS) nebulizer, Spiriva® 18 mcg QD Handihaler
Keywords
Chronic Obstructive Pulmonary Disease, COPD
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.

  • SUN-101 50 mcg BID eFlow (CS) nebulizerDrug

    Also called Glycopyrrolate

    SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

  • Spiriva® 18 mcg QD HandihalerDrug

    Also called (tiotropium)

    Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Study groups in NCT02276222
Study groupRoleWhat they receive
SUN-101 50 mcg BID eFlow (CS) nebulizerExperimentalSUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
Receives: Drug: SUN-101 50 mcg BID eFlow (CS) nebulizer
Spiriva 18 mcg QD HandihalerActive comparatorSpiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Receives: Drug: Spiriva® 18 mcg QD Handihaler

What is being measured

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

  1. Number of Subjects With Treatment-emergent Adverse Events (TEAE)

    A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.

    Measured: Up to Week 48

  2. Percentage of Subjects With Treatment-emergent Adverse Events

    A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.

    Measured: Up to Week 48

  3. Number of Subjects With Treatment-emergent Serious Adverse Events (SAE)

    A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.

    Measured: Up to Week 48

  4. Percentage of Subjects With Treatment-emergent Serious Adverse

    A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.

    Measured: Up to Week 48

  5. Number of Subjects Who Discontinue the Study Due to TEAE

    A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.

    Measured: Up to Week 48

  6. Percentage of Subjects Who Discontinue the Study Due to TEAE

    A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.

    Measured: Up to 48 Weeks

Secondary outcomes (4)

  1. Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke

    All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.

    Measured: Up to Week 48

  2. Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke

    All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.

    Measured: Up to 48 Weeks

  3. Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke

    All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.

    Measured: up to week 48

  4. Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects

    Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the FEV1 values collected at the end of the dosing interval at each clinic visit. The mean change from baseline in trough FEV1 over the 48 week treatment period is calculated by averaging the trough FEV1 changes from baseline across all study visits while subjects are taking randomized treatment.

    Values affected by other medication use were to be set to missing.

    Measured: Up to Week 48

Timeline

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

  1. First posted28 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

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
None (open label)
Enrolment
1,087 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02276222
Sponsor's protocol ID
SUN101-303
Acronym
GOLDEN-5
Status last verified
Feb 2018
First submitted
14 Oct 2014
Last updated
13 Mar 2018
Data monitoring committee
No

Publications

  • Ferguson GT, Goodin T, Tosiello R, Wheeler A, Kerwin E. Long-term safety of glycopyrrolate/eFlow(R) CS in moderate-to-very-severe COPD: Results from the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) 5 randomized study. Respir Med. 2017 Nov;132:251-260. doi: 10.1016/j.rmed.2017.08.020. Epub 2017 Aug 24.

    PubMed 28919143

  • Ferguson GT, Kerwin EM, Donohue JF, Ganapathy V, Tosiello RL, Bollu VK, Rajagopalan K. Health-Related Quality of Life Improvements in Moderate to Very Severe Chronic Obstructive Pulmonary Disease Patients on Nebulized Glycopyrrolate: Evidence from the GOLDEN Studies. Chronic Obstr Pulm Dis. 2018 Jun 6;5(3):193-207. doi: 10.15326/jcopdf.5.3.2017.0178.

    PubMed 30584583

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SUN-101 50 mcg BID eFlow (CS) nebulizer and Spiriva® 18 mcg QD Handihaler in people with Chronic Obstructive Pulmonary Disease (COPD), run by Sunovion Respiratory Development Inc. at 118 sites in 4 countries.

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 9 inclusion and 16 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Russia, Hungary, Czechia. 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 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 13 Mar 2018). 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 Subjects With Treatment-emergent Adverse Events (TEAE) (time frame: Up to Week 48). The study lists 6 primary outcomes in all. 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 NCT02276222, 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 13 Mar 2018.

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