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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)

2018年2月6日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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).

研究の種類

介入

入学 (実際)

275

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

35年～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：EP-101 Placebo
EP-101 Placebo AM + EP-101 Placebo PM
薬：Placebo
EP-101 Placebo AM + EP-101 Placebo PM
他の名前：
  • SUN101
実験的：EP 101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
薬：EP-101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
他の名前：
  • SUN101
実験的：EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
薬：EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
他の名前：
  • SUN101
実験的：EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
薬：EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
他の名前：
  • SUN101
実験的：EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
薬：EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
他の名前：
  • SUN101

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
The Standardized Change From Baseline FEV1 AUC(0-12)
時間枠：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)
時間枠：Day 28
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Day 28
The Peak FEV1 Change From Baseline
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Sunovion Respiratory Development Inc.

捜査官

  • スタディディレクター：Respiratory Medical Director, MD、Sunovion Respiratory Development

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2012年10月1日

一次修了 (実際)

2013年4月1日

研究の完了 (実際)

2013年4月1日

試験登録日

最初に提出

2012年10月10日

QC基準を満たした最初の提出物

2012年10月10日

最初の投稿 (見積もり)

2012年10月15日

学習記録の更新

投稿された最後の更新 (実際)

2018年3月8日

QC基準を満たした最後の更新が送信されました

2018年2月6日

最終確認日

2018年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • EP-101-04 (SUN101)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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