EUCTR2012-003791-40-GB进行中（未招募）不适用
An Investigation of the Efficacy, Tolerability and Safety of a Range of Doses of Orally Inhaled Glycopyrronium Bromide (PSX1002-GB pMDI) in Male and Female Patients with Moderate or Severe Chronic Obstructive Pulmonary Disease - Dose ranging study of glycopyrronium bromide in moderate/severe COPD
Prosonix Limited0 个研究点开始时间: 2012年10月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 age 40-75 years, inclusive
- •2. A clinical diagnosis of moderate to severe COPD according to the GOLD guidelines
- •3. Current smokers or ex-smokers with at least 10-pack year smoking history (e.g., at least one pack/day for 10 years, or 10 packs/day for one year
- •4. Post-bronchodilator FEV1/FVC ratio < 70 % at Screen
- •5. Post-bronchodilator FEV1 = 40 % to < 80 % of predicted at Screen
- •6. Demonstrated to be responsive to ipratropium (defined as at least an 100ml increase in FEV1 following ipratopium 80 µg)
- •7. Ability to perform acceptable spirometry according to the ATS/ERS guidelines
- •8. Willing and able to provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Females who are pregnant or lactating at the Screening Visit, or if of childbearing potential not using one of the following acceptable means of birth control throughout the study:
- •a. Established use of oral, injected or implanted hormonal methods of contraception (for at least one month prior to the Screening Visit)
- •b. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •d. True abstinence when this is in line with the subject’s preferred and usual lifestyle. (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not considered acceptable methods of contraception).
- •e. Bilateral tubal ligation
- •Females are considered to be of childbearing potential unless either:
- •a. Permanently sterilised (e.g. bilateral salpingectomy, bilateral oophorectomy or hysterectomy) or;
- •b. Postmenopausal (i.e. spontaneous amenorrhoea for at least 2 years)
- •2. Current evidence or recent history of any clinically significant 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
- •3. Recent history of hospitalisation due to an exacerbation of airway disease within three months prior to the Screening Visit or randomisation
- •4. Need for increased treatments of COPD within six weeks prior to the Screening Visit or randomisation
- •5. Primary diagnosis of asthma
- •6. Prior lung volume reductions surgery or history of chest/lung irradiation
- •7. Regular use of daily oxygen therapy
- •8. Use of systemic steroids within three months prior to the Screening Visit or during the run-in period
- •9. Respiratory tract infection within six weeks prior to the Screening Visit. Respiratory tract infections acquired during the run-in period will be assessed by the Investigator to determine suitability to continue in the study.
- •10. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease
- •11. History of urinary retention or bladder neck obstructive type symptoms
- •12. History of narrow-angle glaucoma
- •13. Clinically significant abnormal ECG
- •14. Positive Hepatitis B antigen or positive Hepatitis C antibody
- •15. Positive screening test for HIV antibodies
- •16. Current evidence or history of excessive use or abuse of alcohol in the opinion of the Investigator
- •17. Current evidence or history of abusing legal drugs or use of illegal drugs or substances in the opinion of the Investigator
- •18. Donation of 450 ml or more of blood within eight weeks of the Screening Visit
- •19. History of hypersensitivity or intolerance to aerosol medications
- •20. Participation in another investigational drug study where drug was received within 30 days prior to the Screening Visit.
- •21. Inability to comply with study procedures or with study treatment intake, including inability to be trained and/or inability to demonstrate good inhaler technique with Vitalograph AIM®
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