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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

275

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Jasper, Alabama, Forenede Stater, 35501
        • Jasper Summit Research, LLC
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Pulmonary Associates, PA
    • California
      • Fullerton, California, Forenede Stater, 92835
        • California Research Medical Group, Inc.
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA David Geffen School of Medicine
      • Riverside, California, Forenede Stater, 92506
        • Integrated Research Group
      • Sacramento, California, Forenede Stater, 95819
        • Capital Allergy & Respiratory Disease Center
      • San Diego, California, Forenede Stater, 92120
        • Institute of HealthCare Assessment, Inc.
    • Florida
      • Clearwater, Florida, Forenede Stater, 33765
        • Clinical Research of West Florida
      • Tampa, Florida, Forenede Stater, 33603
        • Clinical Research of West Florida
    • Georgia
      • Austell, Georgia, Forenede Stater, 30106
        • Georgia Clinical Research
      • Lawrenceville, Georgia, Forenede Stater, 30046
        • Gwinnett Biomedical Research
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
        • Veritas Clinical Specialities, LTD
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Minnesota Lung Center
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28207
        • American Health Research
      • Raleigh, North Carolina, Forenede Stater, 27607
        • North Carolina Clinical Research
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45242
        • New Horizons Clinical Research
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
        • Clinical Research Institute of Southern Oregon, PC
      • Medford, Oregon, Forenede Stater, 97504
        • Sunstone Medical Research LLC
      • Portland, Oregon, Forenede Stater, 97202
        • Allergy Associates Research Center
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29615
        • Upstate Pharmaceutical Research
      • Greenville, South Carolina, Forenede Stater, 29615
        • Greenville Pharmaceutical Research, Inc
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • South Carolina Pharmaceutical Research
      • Union, South Carolina, Forenede Stater, 29379
        • CU Pharmacuetical Research
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
      • New Braunfels, Texas, Forenede Stater, 78130
        • Central Texas Health Research
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23225
        • Pulmonary Associates of Richmond, Inc.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

35 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: EP-101 Placebo
EP-101 Placebo AM + EP-101 Placebo PM
Medicin: Placebo
EP-101 Placebo AM + EP-101 Placebo PM
Andre navne:
  • SUN101
Eksperimentel: EP 101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
Medicin: EP-101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
Andre navne:
  • SUN101
Eksperimentel: EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
Medicin: EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
Andre navne:
  • SUN101
Eksperimentel: EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
Medicin: EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
Andre navne:
  • SUN101
Eksperimentel: EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
Medicin: EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
Andre navne:
  • SUN101

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Standardized Change From Baseline FEV1 AUC(0-12)
Tidsramme: Day 28
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Day 28
The Standardized Change From Baseline FEV1 AUC(12-24)
Tidsramme: Day 28
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Day 28
The Peak FEV1 Change From Baseline
Tidsramme: 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.
Day 28
The Number of Subjects With Treatment-emergent Adverse Events
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
The Number of Subjects With Treatment-emergent Serious Adverse Events
Tidsramme: 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 Number 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
The Percentage of Subjects With Treatment-emergent Adverse Events
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
The Percentage of Subjects With Treatment-emergent Serious Adverse Events
Tidsramme: 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
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sunovion Respiratory Development Inc.

Efterforskere

  • Studieleder: Respiratory Medical Director, MD, Sunovion Respiratory Development

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2012

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

10. oktober 2012

Først indsendt, der opfyldte QC-kriterier

10. oktober 2012

Først opslået (Skøn)

15. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EP-101-04 (SUN101)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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