A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLDEN-2)
6 februari 2018 bijgewerkt door: Sunovion Respiratory Development Inc.
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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).
Studietype
Ingrijpend
Inschrijving (Werkelijk)
275
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Alabama
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Jasper, Alabama, Verenigde Staten, 35501
- Jasper Summit Research, LLC
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85006
- Pulmonary Associates, PA
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California
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Fullerton, California, Verenigde Staten, 92835
- California Research Medical Group, Inc.
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Los Angeles, California, Verenigde Staten, 90095
- UCLA David Geffen School of Medicine
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Riverside, California, Verenigde Staten, 92506
- Integrated Research Group
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Sacramento, California, Verenigde Staten, 95819
- Capital Allergy & Respiratory Disease Center
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San Diego, California, Verenigde Staten, 92120
- Institute of HealthCare Assessment, Inc.
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Florida
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Clearwater, Florida, Verenigde Staten, 33765
- Clinical Research of West Florida
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Tampa, Florida, Verenigde Staten, 33603
- Clinical Research of West Florida
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Georgia
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Austell, Georgia, Verenigde Staten, 30106
- Georgia Clinical Research
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Lawrenceville, Georgia, Verenigde Staten, 30046
- Gwinnett Biomedical Research
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Kansas
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Topeka, Kansas, Verenigde Staten, 66606
- Veritas Clinical Specialities, LTD
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55407
- Minnesota Lung Center
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28207
- American Health Research
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Raleigh, North Carolina, Verenigde Staten, 27607
- North Carolina Clinical Research
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45242
- New Horizons Clinical Research
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Oregon
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Medford, Oregon, Verenigde Staten, 97504
- Clinical Research Institute of Southern Oregon, PC
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Medford, Oregon, Verenigde Staten, 97504
- Sunstone Medical Research LLC
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Portland, Oregon, Verenigde Staten, 97202
- Allergy Associates Research Center
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South Carolina
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Greenville, South Carolina, Verenigde Staten, 29615
- Upstate Pharmaceutical Research
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Greenville, South Carolina, Verenigde Staten, 29615
- Greenville Pharmaceutical Research, Inc
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Spartanburg, South Carolina, Verenigde Staten, 29303
- South Carolina Pharmaceutical Research
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Union, South Carolina, Verenigde Staten, 29379
- CU Pharmacuetical Research
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Texas
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Houston, Texas, Verenigde Staten, 77030
- Baylor College of Medicine
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New Braunfels, Texas, Verenigde Staten, 78130
- Central Texas Health Research
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Virginia
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Richmond, Virginia, Verenigde Staten, 23225
- Pulmonary Associates of Richmond, Inc.
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
35 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: EP-101 Placebo
EP-101 Placebo AM + EP-101 Placebo PM
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EP-101 Placebo AM + EP-101 Placebo PM
Andere namen:
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Experimenteel: EP 101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
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EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
Andere namen:
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Experimenteel: EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
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EP-101 25 mcg AM + EP-101 25 mcg PM
Andere namen:
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Experimenteel: EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
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EP-101 50 mcg AM + EP-101 50 mcg PM
Andere namen:
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Experimenteel: EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
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EP-101 100 mcg AM + EP-101 100 mcg PM
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Tijdsspanne: Baseline and Day 29
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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).
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Baseline and Day 29
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The Standardized Change From Baseline FEV1 AUC(0-12)
Tijdsspanne: Day 28
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Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
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Day 28
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The Standardized Change From Baseline FEV1 AUC(12-24)
Tijdsspanne: Day 28
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Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
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Day 28
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The Peak FEV1 Change From Baseline
Tijdsspanne: Day 28
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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.
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Day 28
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The Number of Subjects With Treatment-emergent Adverse Events
Tijdsspanne: Baseline up to Day 28
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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.
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Baseline up to Day 28
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The Number of Subjects With Treatment-emergent Serious Adverse Events
Tijdsspanne: Baseline up to Day 28
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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.
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Baseline up to Day 28
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The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
Tijdsspanne: Baseline up to Day 28
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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.
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Baseline up to Day 28
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The Percentage of Subjects With Treatment-emergent Adverse Events
Tijdsspanne: Baseline up to Day 28
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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.
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Baseline up to Day 28
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The Percentage of Subjects With Treatment-emergent Serious Adverse Events
Tijdsspanne: Baseline up to Day 28
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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.
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Baseline up to Day 28
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The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
Tijdsspanne: Baseline up to Day 28
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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.
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Baseline up to Day 28
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie directeur: Respiratory Medical Director, MD, Sunovion Respiratory Development
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2012
Primaire voltooiing (Werkelijk)
1 april 2013
Studie voltooiing (Werkelijk)
1 april 2013
Studieregistratiedata
Eerst ingediend
10 oktober 2012
Eerst ingediend dat voldeed aan de QC-criteria
10 oktober 2012
Eerst geplaatst (Schatting)
15 oktober 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 maart 2018
Laatste update ingediend die voldeed aan QC-criteria
6 februari 2018
Laatst geverifieerd
1 februari 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EP-101-04 (SUN101)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .