A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter, Long-Term Safety Trial of Treatment with Nebulized SUN-101 in Patients with COPD: GOLDEN-5 (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer).

Sunovion Respiratory Development Inc.0 个研究点目标入组 1,050 人开始时间: 2013年8月14日最近更新: 2016年4月11日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 1,050

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. Male or female patients age = 40 years, inclusive.
•2. A clinical diagnosis of COPD according to the GOLD 2014 guidelines.
•3. Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
•4. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 < 80% of predicted normal and > 0.7 L during Screening (Visit 1).
•5. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio < 0.70 during Screening (Visit 1).
•6. Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS guidelines (2005).
•7. Subject, if female = 65 years of age and of child bearing potential,
•must have a negative serum pregnancy test at Visit 1. 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 participation; b) barrier method
•of contraception, eg, condom and /or diaphragm with spermicide while
•participating in the study; and/or c) abstinence.
•8. Willing and able to provide written informed consent.
•9. Willing and able to attend all study visits and adhere to all study assessments and procedures.
•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 630
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 420

排除标准

•1. Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject.
•2. Concomitant clinically significant respiratory disease other than COPD(eg, asthma, tuberculosis, bronchiectasis or other non-specific pulmonary disease).
•3. Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening (Visit 1).
•4. Use of daily oxygen therapy > 12 hours per day.
•5. Respiratory tract infection within 6 weeks prior to Screening (Visit 1).
•6. Use of systemic steroids within 3 months prior to Screening (Visit 1).
•7. 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.
•8. Prolonged QTc (> 450 msec for males and (> 470 msec for females) during Screening (Visit 1), or history of long QT syndrome.
•9. History of or clinically significant ongoing bladder outlflow obstruction or history of catheterization for relief of bladder outlflow obstruction within the previous 6 months.
•10. History of narrow-angle glaucoma.
•11. History of hypersensitivity or intolerance to aerosol medications.
•12. Recent documented history (within the previous 3 months) of substance abuse.
•13. Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator.
•14. Participation in another investigational drug study where drug was received within 30 days prior to Screening (Visit 1), or current participation in another investigational drug trial, including a SUN 101 study.
•15. Previously received SUN-101 (active treatment; formerly known as EP 101).
•16. Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines.

研究者

发起方

Sunovion Respiratory Development Inc.

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