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A Phase IIIb Study to Evaluate the Efficacy of Umeclidinium/Vilanterol (UMEC/VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

2017年10月9日 更新者：GlaxoSmithKline

A 12 Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy of Umeclidinium/Vilanterol 62.5/25mcg in Subjects With COPD

This study is a 12-week, multicenter, randomized, double blind, parallel group, placebo-controlled study.

The purpose of this study is to replicate the therapeutic benefit of UMEC/VI 62.5/25 microgram (mcg) on health-related quality of life as reflected by St. George's Respiratory Questionnaire (SGRQ) scores and symptoms as reflected by rescue medication use observed in the 6 month placebo controlled study (DB2113373). Lung function will be assessed as it provides an objective measure to support the subjective patient reported outcomes of SGRQ and rescue medication use. The study is intended to provide additional evidence to support the use of UMEC/VI for the maintenance treatment of COPD Approximately 496 subjects will be randomized from approximately 62 centers in order to ensure 422 subjects complete 12 weeks of treatment. Eligible subjects will be randomized to UMEC/VI 62.5/25mcg or placebo in a 1:1 ratio. All treatments will be administered once-daily in the morning via a Dry Powder Inhaler (DPI).

There will be a total of 5 clinic visits. The total duration of study participation will be approximately 15 weeks. All subjects will be provided with albuterol/salbutamol to use as needed for the relief of COPD symptoms throughout the run-in and double-blind treatment periods.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

498

段階

  • フェーズ 3

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
    • Arizona
      • Phoenix、Arizona、アメリカ、85006
        • GSK Investigational Site
    • California
      • Upland、California、アメリカ、91786
        • GSK Investigational Site
    • Florida
      • Clearwater、Florida、アメリカ、33765-2616
        • GSK Investigational Site
    • Missouri
      • Saint Charles、Missouri、アメリカ、63301
        • GSK Investigational Site
    • South Carolina
      • Anderson、South Carolina、アメリカ、29621
        • GSK Investigational Site
      • Easley、South Carolina、アメリカ、29640
        • GSK Investigational Site
      • Mount Pleasant、South Carolina、アメリカ、29464
        • GSK Investigational Site
      • Rock Hill、South Carolina、アメリカ、29732
        • GSK Investigational Site
      • Seneca、South Carolina、アメリカ、29678
        • GSK Investigational Site
      • Union、South Carolina、アメリカ、29379
        • GSK Investigational Site
    • Texas
      • San Antonio、Texas、アメリカ、78229
        • GSK Investigational Site
  • ウクライナ
      • Kharkiv、ウクライナ、61124
        • GSK Investigational Site
      • Kharkiv、ウクライナ、61002
        • GSK Investigational Site
      • Kiev、ウクライナ、03680
        • GSK Investigational Site
      • Kyiv、ウクライナ、02232
        • GSK Investigational Site
      • Kyiv、ウクライナ、01114
        • GSK Investigational Site
  • ドイツ
      • Berlin、ドイツ、10717
        • GSK Investigational Site
      • Berlin、ドイツ、10119
        • GSK Investigational Site
      • Berlin、ドイツ、10629
        • GSK Investigational Site
      • Hamburg、ドイツ、22143
        • GSK Investigational Site
    • Hessen
      • Kassel、Hessen、ドイツ、34121
        • GSK Investigational Site
    • Niedersachsen
      • Weyhe-Leeste、Niedersachsen、ドイツ、28844
        • GSK Investigational Site
    • Schleswig-Holstein
      • Reinfeld、Schleswig-Holstein、ドイツ、23858
        • GSK Investigational Site
  • ハンガリー
      • Balassagyarmat、ハンガリー、2660
        • GSK Investigational Site
      • Budapest、ハンガリー、1085
        • GSK Investigational Site
      • Budaörs、ハンガリー、2040
        • GSK Investigational Site
      • Debrecen、ハンガリー、4032
        • GSK Investigational Site
      • Gödöllő、ハンガリー、2100
        • GSK Investigational Site
      • Nyíregyháza、ハンガリー、4400
        • GSK Investigational Site
      • Szeged、ハンガリー、6722
        • GSK Investigational Site
      • Szikszó、ハンガリー、3800
        • GSK Investigational Site
  • ブルガリア
      • Dupnitza、ブルガリア、2600
        • GSK Investigational Site
      • Gabrovo、ブルガリア、5300
        • GSK Investigational Site
      • Kyustendil、ブルガリア、2500
        • GSK Investigational Site
      • Montana、ブルガリア
        • GSK Investigational Site
      • Sevlievo、ブルガリア、5400
        • GSK Investigational Site
      • Sliven、ブルガリア、8800
        • GSK Investigational Site
      • Sofia、ブルガリア、1336
        • GSK Investigational Site
  • ルーマニア
      • Cluj-Napoca、ルーマニア、400371
        • GSK Investigational Site
      • Codlea、ルーマニア、505100
        • GSK Investigational Site
      • Craiova、ルーマニア、200642
        • GSK Investigational Site
      • Deva、ルーマニア、330084
        • GSK Investigational Site
      • Iasi、ルーマニア、700115
        • GSK Investigational Site
      • Pitesti、ルーマニア、110084
        • GSK Investigational Site
  • ロシア連邦
      • Ekaterinburg、ロシア連邦、620039
        • GSK Investigational Site
      • Moscow、ロシア連邦、117997
        • GSK Investigational Site
      • Novosibirsk、ロシア連邦、630099
        • GSK Investigational Site
      • Saint Petesburg、ロシア連邦、195030
        • GSK Investigational Site
      • Sestroretsk、ロシア連邦、197706
        • GSK Investigational Site
      • St. Petersburg、ロシア連邦、194356
        • GSK Investigational Site
      • St. Petersburg、ロシア連邦、198216
        • GSK Investigational Site
      • Stavropol、ロシア連邦、355017
        • GSK Investigational Site
      • Ulyanovsk、ロシア連邦、432063
        • GSK Investigational Site
      • Voronezh、ロシア連邦、394018
        • GSK Investigational Site

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

40年歳以上 (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:

  • Type of subject: Outpatient.
  • Informed Consent: A signed and dated written informed consent prior to study participation.
  • Age: 40 years of age or older at Visit 1.
  • Gender: Male and female subjects are eligible to participate in the study.
  • A female subject is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile (For example [e.g.] age appropriate, >45 years, in the absence of hormone replacement therapy; or child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label, if appropriate, and the instructions of the physician for the duration of the study screening to follow-up contact): abstinence; oral contraceptive (either combined or progestogen alone); injectable progestogen; implants of levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label; male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study (this male is the sole partner for that subject); and double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).
  • Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society.
  • Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g. 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years both equal 10 pack-years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack-year history.
  • Severity of Disease: A pre and post-albuterol/salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of <0.70 and a post-albuterol/salbutamol FEV1 of <=70% of predicted normal values calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations at Visit 1.
  • Dyspnea: A score of >=2 on the Modified Medical Research Council (mMRC) Dyspnea Scale at Visit 1.

Exclusion Criteria:

  • Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
  • Asthma: A current diagnosis of asthma.
  • Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease.
  • Other Diseases/Abnormalities: Any subject who is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediate life-threatening illness (e.g. cancer). In addition, any subject who has any condition (e.g. neurological condition) that is likely to affect respiratory function should not be included in the study.
  • Severe Hepatic Impairment: Patients with severe hepatic impairment (Child-Pugh class C) should be excluded unless, in the opinion of the investigator, the benefit is likely to outweigh the risk.
  • Unstable or life threatening cardiac disease: UMEC/VI should be used with caution in subjects with severe cardiovascular disease. In the opinion of the investigator, use should only be considered if the benefit is likely to outweigh the risk in conditions such as: myocardial infarction or unstable angina in the last 6 months; unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV heart failure.
  • Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, lactose/milk protein or magnesium stearate.
  • Antimuscarinic effects: Subjects with medical conditions such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction should only be included if, in the opinion of the study physician, the benefit outweighs the risk.
  • Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
  • Lung Resection: Lung volume reduction surgery within the 12 months prior to Visit 1.
  • 12-Lead Electrocardiogram (ECG): Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. Subjects with the following abnormalities are excluded from participation in the study: Atrial fibrillation with rapid ventricular rate >120 beats per minute (bpm); Sustained or non-sustained ventricular tachycardia; Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted).
  • Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
  • Interactions: Concomitant administration with beta-blockers and strong Cytochrome P450 3A4 (CYP3A4) inhibitors is only permitted if, in the Investigator's opinion, the likely benefit outweighs the potential risk.
  • Medications Prior to Screening: Use of the following medications according to the following defined time intervals prior to Visit 1: Depot corticosteroids (12 weeks), systemic, oral or parenteral corticosteroids (6 weeks), antibiotics (for lower respiratory tract infection) (6 weeks), Long acting Beta-Agonist (LABA)/ Inhaled Corticosteroid (ICS) combination products if LABA/ICS therapy is discontinued completely (30 days), LABA/ICS combination products only if discontinuing LABA/ICS therapy and switching to ICS monotherapy (48 hours for salmeterol or formoterol component and 14 days for vilanterol component), ICS (dose >1000 mcg/day of fluticasone propionate or equivalent) (30 days), Initiation or discontinuation of ICS use (30 days), Phosphodiesterase 4 (PDE4) Inhibitor (roflumilast) (14 days), Inhaled long acting beta2 agonists (48 hours for salmeterol, formoterol, 14 days for olodaterol, indacaterol), Long-acting muscarinic antagonists (tiotropium, aclidinium, glycopyrronium, umeclidinium) (7 days), LAMA/LABA combination products if LAMA/LABA therapy is discontinued completely (Apply whichever mono component has the longest washout), Theophyllines (48 hours), Oral beta2-agonists (Long-acting [48 hours], short-acting [12 hours]), Inhaled short acting beta2-agonists (4 hours), Inhaled short-acting anticholinergics (4 hours), Inhaled short-acting anticholinergic/short-acting beta2-agonist combination products (4 hours), Any other investigational medication (30 days or within 5 drug half-lives [whichever is longer])
  • Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., <=12 hours per day) is not exclusionary.
  • Nebulised Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulised therapy.
  • Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
  • Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
  • Affiliation with Investigator Site: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study.
  • Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire.
  • Previous participation in DB2113373 study: Subjects who have previously been assigned a subject number (enrolled) in GlaxoSmithKline study DB2113373.

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：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Umeclidinium/Vilanterol 62.5/25 mcg once daily
The subjects will receive UMEC/VI 62.5/25 mcg, administered as one inhalation once-daily in the morning via a dry powder inhaler (DPI)
薬：UMEC/VI
Dry white powder delivered via DPI (2 strips with 30 blisters each, first containing UMEC 62.5 mcg per blister and second containing VI 25 mcg per blister), administered as one inhalation of UMEC/VI 62.5/25 mcg
プラセボコンパレーター：Placebo once daily
The subjects will receive placebo, administered as one inhalation once-daily in the morning via a DPI
薬：Placebo
Dry white powder delivered via DPI (2 strips with 30 blisters each, both containing lactose with magnesium stearate), administered as one inhalation of placebo

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 Mean St.George's Respiratory Questionnaire (SGRQ) Total Score at Day 84
時間枠：Baseline and Day 84
The SGRQ is a disease-specific questionnaire, self-completed by participants(par), used to evaluate the effect of UMEC/VI on health-related quality of life as compared to placebo in par with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Analysis was performed using mixed model repeated measures with covariates of Baseline (scores recorded prior to dosing on Day 1) SGRQ total score, centre group, smoking status, Day, treatment(trt), Day by Baseline interaction and Day by trt interaction, where Day is nominal. Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
Baseline and Day 84

二次結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 84
時間枠：Baseline and Day 84
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 28, 56 and 84. Baseline is defined as the assessment taken pre-dose on Treatment Day 1. Trough FEV1 is defined as the FEV1 value obtained 24 hours after the previous morning's dosing. Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions.
Baseline and Day 84
Change From Baseline (BL) in Mean Number of Puffs of Rescue Medication Per Day Used Over Weeks 1-12
時間枠：Week 1 amd Week 12
Albuterol/salbutamol(A/S) was used as rescue medication and was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout treatment periods. The number of puffs of rescue medication (A/S) per day over the entire 12 week treatment period was recorded and analyzed. For rescue use, 'day' is referred as the period between one record of rescue use and the next. Total puffs of rescue for each day = number of salbutamol puffs + (2 x number of salbutamol nebules). Analysis performed using mixed model repeated measures with covariates of BL(mean number of total puffs over the duration from First Day; defined as Latest of [7 days before Visit 2 and day after Visit 1] to Last Day(defined as Day before Visit 2)), smoking status, centre group, four-week period, treatment and period by BL interaction. Change from BL used weeks 1-4, 5-8, and 9-12 as covariates in the model and the overall least squares mean change for weeks 1-12 is estimated.
Week 1 amd Week 12

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

GlaxoSmithKline

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。

便利なリンク

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

2014年9月1日

一次修了 (実際)

2015年3月1日

研究の完了 (実際)

2015年3月5日

試験登録日

最初に提出

2014年5月29日

QC基準を満たした最初の提出物

2014年5月29日

最初の投稿 (見積もり)

2014年6月2日

学習記録の更新

投稿された最後の更新 (実際)

2017年11月9日

QC基準を満たした最後の更新が送信されました

2017年10月9日

最終確認日

2017年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 201211

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

試験データ・資料

  1. データセット仕様
    情報識別子：201211
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. 注釈付き症例報告書
    情報識別子：201211
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. 個人参加者データセット
    情報識別子：201211
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. 臨床研究報告書
    情報識別子：201211
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. 統計分析計画
    情報識別子：201211
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. インフォームド コンセント フォーム
    情報識別子：201211
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  7. 研究プロトコル
    情報識別子：201211
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register

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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