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 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Faktisk)
275
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Jasper, Alabama, Förenta staterna, 35501
- Jasper Summit Research, LLC
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Arizona
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Phoenix, Arizona, Förenta staterna, 85006
- Pulmonary Associates, PA
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California
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Fullerton, California, Förenta staterna, 92835
- California Research Medical Group, Inc.
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Los Angeles, California, Förenta staterna, 90095
- UCLA David Geffen School of Medicine
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Riverside, California, Förenta staterna, 92506
- Integrated Research Group
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Sacramento, California, Förenta staterna, 95819
- Capital Allergy & Respiratory Disease Center
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San Diego, California, Förenta staterna, 92120
- Institute of HealthCare Assessment, Inc.
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Florida
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Clearwater, Florida, Förenta staterna, 33765
- Clinical Research of West Florida
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Tampa, Florida, Förenta staterna, 33603
- Clinical Research of West Florida
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Georgia
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Austell, Georgia, Förenta staterna, 30106
- Georgia Clinical Research
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Lawrenceville, Georgia, Förenta staterna, 30046
- Gwinnett Biomedical Research
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Kansas
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Topeka, Kansas, Förenta staterna, 66606
- Veritas Clinical Specialities, LTD
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55407
- Minnesota Lung Center
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28207
- American Health Research
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Raleigh, North Carolina, Förenta staterna, 27607
- North Carolina Clinical Research
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45242
- New Horizons Clinical Research
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Oregon
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Medford, Oregon, Förenta staterna, 97504
- Clinical Research Institute of Southern Oregon, PC
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Medford, Oregon, Förenta staterna, 97504
- Sunstone Medical Research LLC
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Portland, Oregon, Förenta staterna, 97202
- Allergy Associates Research Center
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South Carolina
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Greenville, South Carolina, Förenta staterna, 29615
- Upstate Pharmaceutical Research
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Greenville, South Carolina, Förenta staterna, 29615
- Greenville Pharmaceutical Research, Inc
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Spartanburg, South Carolina, Förenta staterna, 29303
- South Carolina Pharmaceutical Research
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Union, South Carolina, Förenta staterna, 29379
- CU Pharmacuetical Research
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Texas
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Houston, Texas, Förenta staterna, 77030
- Baylor College of Medicine
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New Braunfels, Texas, Förenta staterna, 78130
- Central Texas Health Research
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Virginia
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Richmond, Virginia, Förenta staterna, 23225
- Pulmonary Associates of Richmond, Inc.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
35 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: EP-101 Placebo
EP-101 Placebo AM + EP-101 Placebo PM
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EP-101 Placebo AM + EP-101 Placebo PM
Andra namn:
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Experimentell: 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
Andra namn:
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Experimentell: 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
Andra namn:
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Experimentell: 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
Andra namn:
|
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Experimentell: 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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Tidsram: 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).
|
Baseline and Day 29
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The Standardized Change From Baseline FEV1 AUC(0-12)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Baseline up to Day 28
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The Percentage of Subjects With Treatment-emergent Adverse Events
Tidsram: 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.
|
Baseline up to Day 28
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The Percentage of Subjects With Treatment-emergent Serious Adverse Events
Tidsram: 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.
|
Baseline up to Day 28
|
|
The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
Tidsram: 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.
|
Baseline up to Day 28
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Respiratory Medical Director, MD, Sunovion Respiratory Development
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2012
Primärt slutförande (Faktisk)
1 april 2013
Avslutad studie (Faktisk)
1 april 2013
Studieregistreringsdatum
Först inskickad
10 oktober 2012
Först inskickad som uppfyllde QC-kriterierna
10 oktober 2012
Första postat (Uppskatta)
15 oktober 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 mars 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 februari 2018
Senast verifierad
1 februari 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EP-101-04 (SUN101)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .