A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLDEN-2)
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| ClinicalTrials.gov Identifier: NCT01706536 |
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Recruitment Status :
Completed
First Posted : October 15, 2012
Results First Posted : March 8, 2018
Last Update Posted : March 8, 2018
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Sponsor:
Sunovion Respiratory Development Inc.
Information provided by (Responsible Party):
Sunovion Respiratory Development Inc.
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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.
| Condition or disease | Intervention/treatment | 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 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 275 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease: GOLDEN-2 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer) |
| Study Start Date : | October 2012 |
| Actual Primary Completion Date : | April 2013 |
| Actual Study Completion Date : | April 2013 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: EP-101 Placebo
EP-101 Placebo AM + EP-101 Placebo PM
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Drug: Placebo
EP-101 Placebo AM + EP-101 Placebo PM
Other Name: SUN101 |
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Experimental: EP 101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
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Drug: EP-101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
Other Name: SUN101 |
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Experimental: EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
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Drug: EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
Other Name: SUN101 |
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Experimental: EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
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Drug: EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
Other Name: SUN101 |
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Experimental: EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
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Drug: EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
Other Name: SUN101 |
Primary Outcome Measures :
- Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline and Day 29 ]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).
Secondary Outcome Measures :
- The Standardized Change From Baseline FEV1 AUC(0-12) [ Time Frame: Day 28 ]Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
- The Standardized Change From Baseline FEV1 AUC(12-24) [ Time Frame: Day 28 ]Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
- The Peak FEV1 Change From Baseline [ Time Frame: Day 28 ]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.
- The Number of Subjects With Treatment-emergent Adverse Events [ Time Frame: Baseline up to Day 28 ]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.
- The Number of Subjects With Treatment-emergent Serious Adverse Events [ Time Frame: Baseline up to Day 28 ]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.
- The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation [ Time Frame: Baseline up to Day 28 ]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.
- The Percentage of Subjects With Treatment-emergent Adverse Events [ Time Frame: Baseline up to Day 28 ]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.
- The Percentage of Subjects With Treatment-emergent Serious Adverse Events [ Time Frame: Baseline up to Day 28 ]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.
- The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation [ Time Frame: Baseline up to Day 28 ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 35 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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).
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706536
Locations
Show 26 study locations
Sponsors and Collaborators
Sunovion Respiratory Development Inc.
Investigators
| Study Director: | Respiratory Medical Director, MD | Sunovion Respiratory Development |
Publications of Results:
| Responsible Party: | Sunovion Respiratory Development Inc. |
| ClinicalTrials.gov Identifier: | NCT01706536 |
| Other Study ID Numbers: |
EP-101-04 (SUN101) |
| First Posted: | October 15, 2012 Key Record Dates |
| Results First Posted: | March 8, 2018 |
| Last Update Posted: | March 8, 2018 |
| Last Verified: | February 2018 |
Additional relevant MeSH terms:
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Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases |