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Confirmatory Dose Finding Study of 2 Dosages of CHF 4226 pMDI (Carmoterol) in Patients With COPD

2010年8月24日 更新者：Chiesi Farmaceutici S.p.A.

Evaluation of the Effect of 2 Weeks Treatment With CHF 4226 pMDI 2µg and 4µg, Given Once Daily in the Morning, on 24-Hour FEV1 in Patients With COPD

The purpose of this study is to confirm the dose of CHF 4226 (carmoterol) that should be given once a day to patients with COPD in order for the effect to last for 24 hours.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

57

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Arizona
      • Gilbert、Arizona、美国、85295
        • Horizon Clinical Research Associates, PLLC
      • Phoenix、Arizona、美国、85006
        • Pulmonary Associates, PA
    • California
      • Los Angeles、California、美国、90095
        • UCLA David Geffen School of Medicine
    • Florida
      • DeLand、Florida、美国、32720
        • University Clinical Research - Deland, LLC
    • Georgia
      • Austell、Georgia、美国、30106
        • Pulmonary Medicine and Critical Care
    • Illinois
      • Normal、Illinois、美国、61761
        • Sneeze, Wheeze & Itch Associates, LLC
    • Kentucky
      • Madisonville、Kentucky、美国、42431
        • Commonwealth BioMedical Research
    • North Carolina
      • Raleigh、North Carolina、美国、27607
        • North Carolina Clinical Research
    • Ohio
      • Cincinnati、Ohio、美国、45242
        • New Horizons Clinical Research
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73112
        • Lynn Health Science Institute
    • Oregon
      • Medford、Oregon、美国、97504
        • Clinical Research Institute of Southern Oregon, PC
      • Portland、Oregon、美国、97213
        • Asthma Allergy Associates
    • South Carolina
      • Spartanburg、South Carolina、美国、29303
        • Spartanburg Medical Research
    • Texas
      • Sugar Land、Texas、美国、77074
        • Reichman Associates
    • Utah
      • Salt Lake City、Utah、美国、84108
        • University of Utah

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Signed IRB approved Informed Consent form
  • Male or non-pregnant female, 40 -75 years old, inclusive
  • Current or past cigarette smoking history of at least 15 pack-years
  • Clinical diagnosis of COPD in accordance with recommendations of the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD)

  • Patient meets following requirements after FEV1 albuterol reversibility test (i.e., 30 minutes after 200μg (metered dose) albuterol MDI):

    • FEV1/FVC < 70%
    • FEV1 is at least 0.9L
    • FEV1 30% - 80%, inclusive, of patient's predicted normal value; ∆FEV1 > 5% of pre-albuterol value
    • If ∆FEV1 < 5% of pre-albuterol value, requirement must be met after retesting during run-in period, at least 24 hours prior to Period 1/Visit 1.

Exclusion Criteria:

  • History of asthma
  • Blood eosinophil count > 500/microliters
  • History of allergic rhinitis or atopy
  • COPD exacerbation or lower respiratory tract infection within 8 weeks prior to screening, or during run-in period, that resulted in use of an antibiotic, or oral or parenteral corticosteroids
  • Inhaled corticosteroid that has been initiated, or effective dose has been changed, within 4 weeks prior to screening or during run-in period
  • Uncontrolled cardiovascular (e.g., uncontrolled hypertension), respiratory, hematologic, immunologic, renal, neurologic, hepatic, endocrine (e.g., uncontrolled diabetes mellitus) or other disease, or any condition that might, in Investigator's judgment, place patient at undue risk or potentially compromise study results or interpretation
  • History of coronary artery disease, cerebrovascular disease, cardiac arrhythmias
  • Lung cancer or history of lung cancer
  • Active cancer or history of cancer with < 5 years disease free survival time (with or without evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of skin is acceptable.
  • Serum potassium value ≤ 3.5 mEq/L or > 5.5mEq/L and/or fasting serum glucose value ≥ 140 mg/dL
  • Abnormal QTcF interval value in Screening visit ECG test (i.e., > 450 msec in males or > 470 msec in females)
  • Cor Pulmonale
  • Long term oxygen therapy, i.e., > 16 hours/24-hour period, every day, unless patient resides at elevation > 4000ft

  • Use of any of the following medications prior to Screening, without meeting specified minimum washout period:

    • Long acting anti-cholinergic agent (i.e., tiotropium): 7 days
    • Short acting anti-cholinergics: 8 hours
    • Fixed combinations of β2-agonists and inhaled corticosteroids: 48 hours
    • Fixed combinations of an anti-cholinergic and short acting β2-agonist: 8 hours
  • Long-acting β2-agonists: 48 hours
  • Short acting β2-agonists (other than those prescribed in the study): 6 hours
  • Theophylline and other xanthines: 1 week
  • Parenteral or oral corticosteroids: 1 month
  • Patient has taken any non-permitted medication
  • Patient has received live-attenuated virus vaccination within two weeks prior to screening or during run-in (inactivated Influenza vaccination is acceptable if given > 48 hours prior to Screening)
  • Known intolerance/hypersensitivity to β2-adrenergic agonists, propellant gases/excipients
  • Patient is pregnant or lactating female, or female at risk of pregnancy (i.e., not using adequate contraceptive method: surgical sterilization [e.g., bilateral tubal ligation], hormonal contraception [implantable, patch, oral], IUD, and double-barrier methods [any double combination of: male or female condom with spermicidal gel, diaphragm, sponge, cervical cap]).
  • Patient is mentally or legally incapacitated
  • Patient has participated in another investigational study within 30 days prior to screening
  • Abuse of alcohol or other substances
  • Patient does not maintain regular day/night, waking/sleeping cycles (e.g., night shift worker)
  • Patient is potentially non-compliant or unable to perform required protocol outcome measurements

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：A
CHF 4226 (carmoterol) 2 μg once a day, in the morning
药品：carmoterol (CHF 4226)

carmoterol (CHF 4226) 2 μg once a day, in the morning

(1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)

其他名称：
  • 瑞士法郎 4226
  • TA2005
药品：carmoterol (CHF 4226)

carmoterol (CHF 4226) 4 μg once a day, in the morning

(1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)

其他名称：
  • 瑞士法郎 4226
  • TA2005
实验性的：B
CHF 4226 (carmoterol) 4 μg once a day, in the morning
药品：carmoterol (CHF 4226)

carmoterol (CHF 4226) 2 μg once a day, in the morning

(1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)

其他名称：
  • 瑞士法郎 4226
  • TA2005
药品：carmoterol (CHF 4226)

carmoterol (CHF 4226) 4 μg once a day, in the morning

(1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)

其他名称：
  • 瑞士法郎 4226
  • TA2005
安慰剂比较：C
placebo once a day, in the morning
药品：placebo

placebo once a day, in the morning

(1 puff of placebo pMDI + 1 puff of placebo pMDI)
有源比较器：D
salmeterol 50 μg twice daily, in the morning and in the evening
药品：salmeterol

Salmeterol 50 μg twice daily, in the morning and in the evening

(1 blister of Serevent Diskus BID)

其他名称：
  • Serevent Diskus/Accuhaler

研究衡量的是什么？

主要结果指标

结果测量
大体时间
FEV1 AUC0-24 standardized by time
大体时间：on Day 15 (after 14 days of dosing)
on Day 15 (after 14 days of dosing)

次要结果测量

结果测量
大体时间
FEV1(L)
大体时间：30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods
30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods
blood pressure
大体时间：at the beginning and end of each of the four 14-day treatment periods
at the beginning and end of each of the four 14-day treatment periods
heart rate
大体时间：at the beginning and end of each of the four 14-day treatment periods
at the beginning and end of each of the four 14-day treatment periods
FEV1 percent change
大体时间：30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods
30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chiesi Farmaceutici S.p.A.

调查人员

  • 研究主任：Steven E. Linberg, PhD、Chiesi Farmaceutici S.p.A.
  • 首席研究员：Donald P. Tashkin, MD、University of California, Los Angeles

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年4月1日

初级完成 (实际的)

2008年10月1日

研究完成 (实际的)

2008年10月1日

研究注册日期

首次提交

2008年3月18日

首先提交符合 QC 标准的

2008年3月18日

首次发布 (估计)

2008年3月21日

研究记录更新

最后更新发布 (估计)

2010年8月27日

上次提交的符合 QC 标准的更新

2010年8月24日

最后验证

2010年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CCD-0706-PR-0026

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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