AzTrials
AzTrials

COPDPhase 2GOLDEN-2NCT01706536

A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Phase 2 study testing EP-101 12.5 mcg, EP-101 25 mcg and EP-101 50 mcg in people with COPD, run by Sunovion Respiratory Development Inc. at 26 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 randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
COPD
What is being tested?
EP-101 12.5 mcg, EP-101 25 mcg and EP-101 50 mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
275 participants
Where
26 sitesUnited States
Study dates
Oct 2012to Apr 2013
Phase
Phase 2
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 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects age 35 through 75 years, inclusive.
  • A clinical diagnosis of moderate to severe COPD according to GOLD guidelines (2011).
  • 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 MDI) FEV1 ≥ 30% and ≤ 70% of predicted normal value during the Screening Period.
  • Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1/FVC ratio < 0.70 during the Screening Period.
  • Post-bronchodilator (following inhalation of ipratropium bromide MDI) improvement in FEV1 ≥ 12% and ≥ 100 mL during the Screening Period.
Show all 12Show fewer
  • Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).
  • Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at screening. 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 study participation.
  • b. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
  • c. Abstinence.
  • Willing and able to provide written informed consent.

Who cannot join

  • 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.
  • Current evidence or history of clinically significant abnormal cardiac rhythm and/or conduction findings, including Holter monitoring results during the Screening Period.
  • Concomitant pulmonary disease or primary diagnosis of asthma.
  • 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
  • Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to the Screening Period.
  • Use of daily oxygen therapy > 10 hours per day.
Show all 16Show fewer
  • Use of systemic steroids within 3 months prior to the Screening Period.
  • Respiratory tract infection within 6 weeks prior to or during the Screening Period.
  • History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
  • History of urinary retention or bladder neck obstruction type symptoms.
  • History of narrow-angle glaucoma.
  • Prolonged QTc interval (> 450msec for males and > 470msec for females) during the Screening Period, or history of long QT syndrome.
  • Recent history (previous 12 months) of excessive use or abuse of narcotic/illegal drugs.
  • History of hypersensitivity or intolerance to β2-agonists or anticholinergics.
  • Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period.
  • Female subject who is pregnant or lactating

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • Georgia Clinical Research

    Austell, Georgia, 30106

  • American Health Research

    Charlotte, North Carolina, 28207

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • California Research Medical Group, Inc.

    Fullerton, California, 92835

  • Greenville Pharmaceutical Research, Inc

    Greenville, South Carolina, 29615

  • Upstate Pharmaceutical Research

    Greenville, South Carolina, 29615

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Jasper Summit Research, LLC

    Jasper, Alabama, 35501

  • Gwinnett Biomedical Research

    Lawrenceville, Georgia, 30046

  • UCLA David Geffen School of Medicine

    Los Angeles, California, 90095

  • Clinical Research Institute of Southern Oregon, PC

    Medford, Oregon, 97504

  • Sunstone Medical Research LLC

    Medford, Oregon, 97504

  • Minnesota Lung Center

    Minneapolis, Minnesota, 55407

  • Central Texas Health Research

    New Braunfels, Texas, 78130

  • Pulmonary Associates, PA

    Phoenix, Arizona, 85006

  • Allergy Associates Research Center

    Portland, Oregon, 97202

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23225

  • Integrated Research Group

    Riverside, California, 92506

  • Capital Allergy & Respiratory Disease Center

    Sacramento, California, 95819

  • Institute of HealthCare Assessment, Inc.

    San Diego, California, 92120

  • South Carolina Pharmaceutical Research

    Spartanburg, South Carolina, 29303

  • Clinical Research of West Florida

    Tampa, Florida, 33603

  • Veritas Clinical Specialities, LTD

    Topeka, Kansas, 66606

  • CU Pharmacuetical Research

    Union, South Carolina, 29379

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of EP-101 (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease: GOLDEN-2 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011). The primary analysis will compare each of the EP-101 (SUN101) dose groups to placebo with respect to the change from baseline in morning trough FEV1 on Day 29. Trough FEV1 is defined as the mean of the two FEV1 values obtained at 23 hours 30 minutes and 24 hours after Day 28 AM dose (ie, approximately 12 hours after the previous PM dose).

Conditions
COPD
Being tested
Placebo, EP-101 12.5 mcg, EP-101 25 mcg, EP-101 50 mcg, EP-101 100 mcg
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.

  • PlaceboDrug

    Also called SUN101

    EP-101 Placebo AM + EP-101 Placebo PM

  • EP-101 12.5 mcgDrug

    Also called SUN101

    EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

  • EP-101 25 mcgDrug

    Also called SUN101

    EP-101 25 mcg AM + EP-101 25 mcg PM

  • EP-101 50 mcgDrug

    Also called SUN101

    EP-101 50 mcg AM + EP-101 50 mcg PM

  • EP-101 100 mcgDrug

    Also called SUN101

    EP-101 100 mcg AM + EP-101 100 mcg PM

Study groups in NCT01706536
Study groupRoleWhat they receive
EP-101 PlaceboPlacebo comparatorEP-101 Placebo AM + EP-101 Placebo PM
Receives: Drug: Placebo
EP 101 12.5 mcgExperimentalEP-101 12.5 mcg AM + EP-101 12.5 mcg PM
Receives: Drug: EP-101 12.5 mcg
EP-101 25 mcgExperimentalEP-101 25 mcg AM + EP-101 25 mcg PM
Receives: Drug: EP-101 25 mcg
EP-101 50 mcgExperimentalEP-101 50 mcg AM + EP-101 50 mcg PM
Receives: Drug: EP-101 50 mcg
EP-101 100 mcgExperimentalEP-101 100 mcg AM + EP-101 100 mcg PM
Receives: Drug: EP-101 100 mcg

What is being measured

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

  1. Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)

    Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours after the in-clinic morning dose (i.e. approximately 12 hrs after the previous evening dose).

    Measured: Baseline and Day 29

Secondary outcomes (9)

  1. The Standardized Change From Baseline FEV1 AUC(0-12)

    Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.

    Measured: Day 28

  2. The Standardized Change From Baseline FEV1 AUC(12-24)

    Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.

    Measured: Day 28

  3. The Peak FEV1 Change From Baseline

    Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Peak FEV1 is defined as the highest postdose FEV1 value within 4 hrs after the morning dose.

    Measured: Day 28

  4. The Number of Subjects With Treatment-emergent Adverse Events

    Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.

    Measured: Baseline up to Day 28

  5. The Number of Subjects With Treatment-emergent Serious Adverse Events

    Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.

    Measured: Baseline up to Day 28

  6. The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation

    Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.

    Measured: Baseline up to Day 28

  7. The Percentage of Subjects With Treatment-emergent Adverse Events

    Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.

    Measured: Baseline up to Day 28

  8. The Percentage of Subjects With Treatment-emergent Serious Adverse Events

    Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.

    Measured: Baseline up to Day 28

  9. The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation

    Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.

    Measured: Baseline up to Day 28

Timeline

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

  1. First posted15 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionApr 2013
  4. Study completionApr 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01706536
Sponsor's protocol ID
EP-101-04 (SUN101)
Acronym
GOLDEN-2
Status last verified
Feb 2018
First submitted
10 Oct 2012
Last updated
8 Mar 2018
Data monitoring committee
No

Publications

  • Donohue JF, Goodin T, Tosiello R, Wheeler A. Dose selection for glycopyrrolate/eFlow(R) phase III clinical studies: results from GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) phase II dose-finding studies. Respir Res. 2017 Dec 4;18(1):202. doi: 10.1186/s12931-017-0681-z.

    PubMed 29202767

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EP-101 12.5 mcg, EP-101 25 mcg and EP-101 50 mcg in people with COPD, run by Sunovion Respiratory Development Inc. at 26 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 12 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 8 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 26 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 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?

Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) (time frame: Baseline and Day 29). 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 NCT01706536, which also lists 1 linked publication.

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 8 Mar 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in