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

NCT ID: NCT01706536

Last Updated: 2018-03-08

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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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

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EP-101 Placebo

EP-101 Placebo AM + EP-101 Placebo PM

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

EP-101 Placebo AM + EP-101 Placebo PM

EP 101 12.5 mcg

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

Group Type EXPERIMENTAL

EP-101 12.5 mcg

Intervention Type DRUG

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

EP-101 25 mcg

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

Group Type EXPERIMENTAL

EP-101 25 mcg

Intervention Type DRUG

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

EP-101 50 mcg

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

Group Type EXPERIMENTAL

EP-101 50 mcg

Intervention Type DRUG

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

EP-101 100 mcg

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

Group Type EXPERIMENTAL

EP-101 100 mcg

Intervention Type DRUG

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

Interventions

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Placebo

EP-101 Placebo AM + EP-101 Placebo PM

Intervention Type DRUG

EP-101 12.5 mcg

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

Intervention Type DRUG

EP-101 25 mcg

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

Intervention Type DRUG

EP-101 50 mcg

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

Intervention Type DRUG

EP-101 100 mcg

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

Intervention Type DRUG

Other Intervention Names

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SUN101 SUN101 SUN101 SUN101 SUN101

Eligibility Criteria

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Inclusion Criteria

* 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.
* 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.

Exclusion Criteria

* 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.
* 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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunovion Respiratory Development Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Respiratory Medical Director, MD

Role: STUDY_DIRECTOR

Sunovion Respiratory Development

Locations

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Jasper Summit Research, LLC

Jasper, Alabama, United States

Site Status

Pulmonary Associates, PA

Phoenix, Arizona, United States

Site Status

California Research Medical Group, Inc.

Fullerton, California, United States

Site Status

UCLA David Geffen School of Medicine

Los Angeles, California, United States

Site Status

Integrated Research Group

Riverside, California, United States

Site Status

Capital Allergy & Respiratory Disease Center

Sacramento, California, United States

Site Status

Institute of HealthCare Assessment, Inc.

San Diego, California, United States

Site Status

Clinical Research of West Florida

Clearwater, Florida, United States

Site Status

Clinical Research of West Florida

Tampa, Florida, United States

Site Status

Georgia Clinical Research

Austell, Georgia, United States

Site Status

Gwinnett Biomedical Research

Lawrenceville, Georgia, United States

Site Status

Veritas Clinical Specialities, LTD

Topeka, Kansas, United States

Site Status

Minnesota Lung Center

Minneapolis, Minnesota, United States

Site Status

American Health Research

Charlotte, North Carolina, United States

Site Status

North Carolina Clinical Research

Raleigh, North Carolina, United States

Site Status

New Horizons Clinical Research

Cincinnati, Ohio, United States

Site Status

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, United States

Site Status

Sunstone Medical Research LLC

Medford, Oregon, United States

Site Status

Allergy Associates Research Center

Portland, Oregon, United States

Site Status

Greenville Pharmaceutical Research, Inc

Greenville, South Carolina, United States

Site Status

Upstate Pharmaceutical Research

Greenville, South Carolina, United States

Site Status

South Carolina Pharmaceutical Research

Spartanburg, South Carolina, United States

Site Status

CU Pharmacuetical Research

Union, South Carolina, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Central Texas Health Research

New Braunfels, Texas, United States

Site Status

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 29202767 (View on PubMed)

Other Identifiers

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EP-101-04 (SUN101)

Identifier Type: -

Identifier Source: org_study_id

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