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临床试验/EUCTR2010-024640-15-GR
EUCTR2010-024640-15-GR进行中（未招募）不适用

A randomized, double-blind, placebo-controlled ‘Proof of Concept’ study of 12 week treatment with RBx 10017609 in subjects with moderate to severe chronic obstructive pulmonary disease (COPD). - RBx 10017609 tablets in COPD

Ranbaxy Laboratories Limited0 个研究点目标入组 135 人开始时间: 2012年8月9日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
135
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1. Subjects who have signed an informed consent consistent with ICH-GCP guidelines prior to participation in the trial at prescreening visit.
  • •2. Male or female subjects, aged =40 years. Female subjects should be of non-childbearing potential [post menopausal* or those who have undergone surgical sterility (hysterectomy/bilateral tubal ligation/ bilateral oophorectomy)].
  • •Sexually active male subjects should agree to use a medically accepted form of contraception (barrier method) or must have undergone vasectomy in the past and their partner should be either using a medically acceptable form of contraception (oral contraceptives, intrauterine contraceptive devices) or have undergone tubal ligation in the past.
  • •3. Subjects with clinical diagnosis of COPD as defined by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009 and who additionally have:
  • •- smoking history of at least 10 pack years** (current and former smokers)
  • •- post-bronchodilator FEV1 to FVC ratio of <0.70 at screening (Visit 2).
  • •- post-bronchodilator FEV1 of =30% and =70% of the predicted normal value at screening. Post-bronchodilator refers to within 15-30 min. of inhalation of 4x100 mcg of salbutamol delivered at mouth piece (Visit 2).
  • •*Menopause is defined as the time when there has been no menstrual period for 12 consecutive months and no other biological or physiological cause can be identified (diagnosed on the basis of age appropriateness and history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with FSH levels greater than 40 mIU/mL at screening.
  • •**Number of pack years = (number of cigarettes/bidis smoked per day x number of years smoked)/20.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 10
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 5

排除标准

  • •1. Subjects with history of hypersensitivity to study medication / drugs of similar class or ß2-agonists or any of the excipients contained in any of these formulations.
  • •2. Subjects with Body Mass Index (BMI) of <18 or >35 kg/m2 at screening (Visit 2).
  • •3. Pregnant* or nursing women or women of child bearing potential**.
  • •4. Subjects having alpha-1 antitrypsin deficiency.
  • •5. Subjects with history of asthma***.
  • •6. Subjects with active pulmonary tuberculosis, lung or any other malignancy, bronchiectasis, cystic fibrosis or pneumonia
  • •7. Subjects using inhaled corticosteroids (ICS) and unable to stop these during the screening/run-in period.
  • •8. Subjects who have received treatment with oral or parenteral glucocorticosteroids within 6 weeks of screening/run-in period or depot corticosteroids within 12 weeks of screening/run-in period.
  • •9. Subjects with history of COPD exacerbation requiring systemic glucocorticosteroids and/or antibiotics and/or hospitalization within 6 weeks of screening****(Visit 2).
  • •10. Subjects with history of respiratory tract infection within 6 weeks of screening visit (Visit 2).
  • •Subjects who develop a respiratory tract infection between pre-screening (Visit 1) and randomization (Visit 3) must discontinue from the trial but may be permitted to re-enroll at a later date once the inclusion/exclusion criteria have been met.
  • •11. Subjects with hypoxemia (SpO2 < 88% on room air).
  • •12. Subjects with significant disease(s), disorder(s) other than COPD that in the opinion of the Investigator may (i) put the subject at risk because of participation in the study or (ii) interfere with the study evaluations or (iii) cause concern regarding subject’s ability to participate in the study.
  • •13. Subjects having arthritis/connective tissue disorder or any other joint disorder that in the opinion of the Investigator might interfere with the study evaluations
  • •14. Subjects with history of consistent abnormal fasting blood sugar (>250 mg/dl or 14 mmol/L) or HbA1c greater than 8% at screening (Visit 2).
  • •15. Subjects with family history of long QT syndrome.
  • •16. Subjects with clinically significant abnormal 12-lead ECG or QTc >450 milliseconds as calculated by Fridericia formula (QTc = QT/RR0.33).
  • •17. Subjects with history of any lung surgery (e.g., lung resection etc.).
  • •18. Subjects with conditions which, in the opinion of the Investigator, prevent subjects from performing spirometry (e.g., hemoptysis of unknown origin, recent eye surgery etc.).
  • •19. Subjects requiring assisted ventilation or subjects who regularly use daytime oxygen therapy for more than 1 hour per day.
  • •20. Subjects with clinically significant abnormal haematology, biochemistry, or urinalysis; all subjects with an SGOT (AST) or SGPT (ALT) >2 times ULN or total bilirubin or serum creatinine >1.2 times ULN (Visit 2).
  • •21. Subjects with a history of HIV or positive serology results for Hepatitis B or C in the past 3 months prior to screening (Visit 2).
  • •22. Subjects with history of habitual alcohol consumption exceeding an average weekly intake of >21 units for males and >14 units for females***** .
  • •23. Subjects with history of drug abuse.
  • •24. Subjects who have received live attenuated vaccination within 4 weeks prior to screening****** (Visit 2).
  • •25. Subjects who have received any other investigational drug within the last 3 months of screening visit (Visit 2).
  • •26. Subjects who have previously

研究者

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