EUCTR2009-010821-38-GB进行中（未招募）不适用
Single-Dose, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Bronchodilatory Effects of Glycopyrrolate Inhalation Solution (GIS) Using a High Efficiency Nebulizer in Patients with COPD
Elevation Pharmaceuticals, Inc0 个研究点目标入组 12 人开始时间: 2009年4月9日最近更新:
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
- 12
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
- •Male or female patients will be eligible for the study if they meet all of the following inclusion criteria:
- •1. Male and female patients age 40 through 65 years, inclusive
- •2. A clinical diagnosis of COPD according to the GOLD guidelines
- •3. Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10 years, or 10 packs/day for 1 year)
- •4. Post-bronchodilator FEV1 40-80% of predicted normal
- •5. Post-bronchodilator FEV1/FVC ratio < 0.70
- •6. Improvement in FEV1 >12% (and 150 mL) following inhalation of ipratropium bromide
- •7. Ability to perform reproducible spirometry according to the ATS/ERS guidelines
- •8. If female and of childbearing potential, must have a negative pregnancy test and not lactating at the Screening Visit, and must be using one of the following acceptable means of birth control throughout the study:
- •- Post-menopausal for at least two years
- •- Surgically sterile
- •- Oral contraceptives (taken for at least one month prior to the Screening Visit)
- •- Approved implantable or injectable contraceptives (e.g., Norplant®,
- •Depo- Provera® or equivalent)
- •- Barrier methods (e.g., condoms with spermicide)
- •- Intrauterine device (i.e., IUD)
- •- Vasectomy of male partner
- •- Non-heterosexual life style
- •9. Willing and able to provide written informed consent
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be eligible for the study if they do not meet any of the following exclusion criteria:
- •1. 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 subjects at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, hypertension, arrhythmia, diabetes, neurological or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities
- •2. Recent history of an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit
- •3. Regular use of daily oxygen therapy
- •4. Use of systemic steroids within 3 months prior to the Screening Visit
- •5. Respiratory tract infection within 6 weeks prior to the Screening Visit
- •6. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease
- •7. History of urinary retention or bladder neck obstruction type symptoms
- •8. History of narrow-angle glaucoma
- •9. Current or recent history (previous 12 months) of excessive use or abuse of alcohol
- •10. Current evidence or history of abusing legal drugs or use of illegal drugs or substances
- •11. History of hypersensitivity or intolerance to aerosol medications
- •12. Participation in another investigational drug study within 30 days prior to the Screening Visit
研究者
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