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

NCT01706536 | Completed Phase 2 Results

• 1 other identifier: EP-101-04 (SUN101)
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 26

Brief 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.

Conditions

COPD

Outcome Measures

Primary Outcomes (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).

  Baseline and Day 29

Secondary Outcomes (9)

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

  Day 28

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

  Day 28

• The Peak FEV1 Change From Baseline

  Day 28

• The Number of Subjects With Treatment-emergent Adverse Events

  Baseline up to Day 28

• The Number of Subjects With Treatment-emergent Serious Adverse Events

  Baseline up to Day 28

Study Arms (5)

EP-101 Placebo

PLACEBO COMPARATOR

EP-101 Placebo AM + EP-101 Placebo PM

Drug: Placebo

EP 101 12.5 mcg

EXPERIMENTAL

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

Drug: EP-101 12.5 mcg

EP-101 25 mcg

EXPERIMENTAL

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

Drug: EP-101 25 mcg

EP-101 50 mcg

EXPERIMENTAL

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

Drug: EP-101 50 mcg

EP-101 100 mcg

EXPERIMENTAL

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

Drug: EP-101 100 mcg

Interventions

Placebo DRUG

EP-101 Placebo AM + EP-101 Placebo PM

Also known as: SUN101

EP-101 Placebo

EP-101 12.5 mcg DRUG

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

Also known as: SUN101

EP 101 12.5 mcg

EP-101 25 mcg DRUG

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

Also known as: SUN101

EP-101 25 mcg

EP-101 50 mcg DRUG

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

Also known as: SUN101

EP-101 50 mcg

EP-101 100 mcg DRUG

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

Also known as: SUN101

EP-101 100 mcg

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunovion Respiratory Development Inc.: lead

Study Sites (26)

Jasper Summit Research, LLC

Jasper, Alabama, 35501, United States

Location

Pulmonary Associates, PA

Phoenix, Arizona, 85006, United States

Location

California Research Medical Group, Inc.

Fullerton, California, 92835, United States

Location

UCLA David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

Integrated Research Group

Riverside, California, 92506, United States

Location

Capital Allergy & Respiratory Disease Center

Sacramento, California, 95819, United States

Location

Institute of HealthCare Assessment, Inc.

San Diego, California, 92120, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33603, United States

Location

Georgia Clinical Research

Austell, Georgia, 30106, United States

Location

Gwinnett Biomedical Research

Lawrenceville, Georgia, 30046, United States

Location

Veritas Clinical Specialities, LTD

Topeka, Kansas, 66606, United States

Location

Minnesota Lung Center

Minneapolis, Minnesota, 55407, United States

Location

American Health Research

Charlotte, North Carolina, 28207, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, 97504, United States

Location

Sunstone Medical Research LLC

Medford, Oregon, 97504, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97202, United States

Location

Greenville Pharmaceutical Research, Inc

Greenville, South Carolina, 29615, United States

Location

Upstate Pharmaceutical Research

Greenville, South Carolina, 29615, United States

Location

South Carolina Pharmaceutical Research

Spartanburg, South Carolina, 29303, United States

Location

CU Pharmacuetical Research

Union, South Carolina, 29379, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, 23225, United States

Location

Related Publications (1)

• 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.

  PMID: 29202767 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Respiratory Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

clinicaltrialsdisclosure@sunovion.com

1-866-503-6351

Study Officials

• Respiratory Medical Director, MD

  Sunovion Respiratory Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 15, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 8, 2018
• Results First Posted: March 8, 2018

Record last verified: 2018-02

Locations

US (26)