A Study of the Efficacy and Safety of EP-101 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLDEN-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier:
NCT01706536
First received: October 10, 2012
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
COPD
Drug: Placebo
Drug: EP-101 12.5 mcg
Drug: EP-101 25 mcg
Drug: EP-101 50 mcg
Drug: EP-101 100 mcg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of EP-101 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease: GOLDEN-2 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

Resource links provided by NLM:


Further study details as provided by Sunovion Respiratory Development Inc.:

Primary Outcome Measures:
  • Change from baseline in morning trough FEV1 [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The standardized change from baseline FEV1 AUC(0-12) [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
  • The standardized change from baseline FEV1 AUC(12-24) [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
  • The peak FEV1 change from baseline [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
  • The number and percentage of subjects with treatment-emergent adverse events [ Time Frame: Baseline up to Day 28 ] [ Designated as safety issue: Yes ]
  • The number and percentage of subjects with treatment-emergent serious adverse events [ Time Frame: Baseline up to Day 28 ] [ Designated as safety issue: Yes ]
  • The number and percentage of subjects with treatment-emergent adverse events leading to study medication discontinuation [ Time Frame: Baseline up to Day 28 ] [ Designated as safety issue: Yes ]

Enrollment: 275
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: EP-101 Placebo
EP-101 Placebo AM + EP-101 Placebo PM
Drug: Placebo
EP-101 Placebo AM + EP-101 Placebo PM
Experimental: EP 101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
Drug: EP-101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
Experimental: EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
Drug: EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
Experimental: EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
Drug: EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
Experimental: EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
Drug: EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM

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 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).

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706536

  Show 26 Study Locations
Sponsors and Collaborators
Sunovion Respiratory Development Inc.
Investigators
Study Director: Respiratory Medical Director, MD Sunovion Respiratory Development
  More Information

No publications provided

Responsible Party: Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier: NCT01706536     History of Changes
Other Study ID Numbers: EP-101-04
Study First Received: October 10, 2012
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014