A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLDEN-2)
6. februar 2018 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
275
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Jasper, Alabama, Forente stater, 35501
- Jasper Summit Research, LLC
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Arizona
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Phoenix, Arizona, Forente stater, 85006
- Pulmonary Associates, PA
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California
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Fullerton, California, Forente stater, 92835
- California Research Medical Group, Inc.
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Los Angeles, California, Forente stater, 90095
- UCLA David Geffen School of Medicine
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Riverside, California, Forente stater, 92506
- Integrated Research Group
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Sacramento, California, Forente stater, 95819
- Capital Allergy & Respiratory Disease Center
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San Diego, California, Forente stater, 92120
- Institute of HealthCare Assessment, Inc.
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Florida
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Clearwater, Florida, Forente stater, 33765
- Clinical Research of West Florida
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Tampa, Florida, Forente stater, 33603
- Clinical Research of West Florida
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Georgia
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Austell, Georgia, Forente stater, 30106
- Georgia Clinical Research
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Lawrenceville, Georgia, Forente stater, 30046
- Gwinnett Biomedical Research
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Kansas
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Topeka, Kansas, Forente stater, 66606
- Veritas Clinical Specialities, LTD
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55407
- Minnesota Lung Center
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North Carolina
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Charlotte, North Carolina, Forente stater, 28207
- American Health Research
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Raleigh, North Carolina, Forente stater, 27607
- North Carolina Clinical Research
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Ohio
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Cincinnati, Ohio, Forente stater, 45242
- New Horizons Clinical Research
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Oregon
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Medford, Oregon, Forente stater, 97504
- Clinical Research Institute of Southern Oregon, PC
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Medford, Oregon, Forente stater, 97504
- Sunstone Medical Research LLC
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Portland, Oregon, Forente stater, 97202
- Allergy Associates Research Center
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South Carolina
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Greenville, South Carolina, Forente stater, 29615
- Upstate Pharmaceutical Research
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Greenville, South Carolina, Forente stater, 29615
- Greenville Pharmaceutical Research, Inc
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Spartanburg, South Carolina, Forente stater, 29303
- South Carolina Pharmaceutical Research
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Union, South Carolina, Forente stater, 29379
- CU Pharmacuetical Research
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Texas
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Houston, Texas, Forente stater, 77030
- Baylor College of Medicine
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New Braunfels, Texas, Forente stater, 78130
- Central Texas Health Research
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Virginia
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Richmond, Virginia, Forente stater, 23225
- Pulmonary Associates of Richmond, Inc.
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
35 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: EP-101 Placebo
EP-101 Placebo AM + EP-101 Placebo PM
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EP-101 Placebo AM + EP-101 Placebo PM
Andre navn:
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Eksperimentell: 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
Andre navn:
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Eksperimentell: 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
Andre navn:
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Eksperimentell: 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
Andre navn:
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Eksperimentell: 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
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Tidsramme: 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).
|
Baseline and Day 29
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The Standardized Change From Baseline FEV1 AUC(0-12)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 Serious Adverse Events
Tidsramme: 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.
|
Baseline up to Day 28
|
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The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Respiratory Medical Director, MD, Sunovion Respiratory Development
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2012
Primær fullføring (Faktiske)
1. april 2013
Studiet fullført (Faktiske)
1. april 2013
Datoer for studieregistrering
Først innsendt
10. oktober 2012
Først innsendt som oppfylte QC-kriteriene
10. oktober 2012
Først lagt ut (Anslag)
15. oktober 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. mars 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. februar 2018
Sist bekreftet
1. februar 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EP-101-04 (SUN101)
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