EUCTR2005-005044-40-GB进行中（未招募）1 期
A Phase 2a Study To Investigate The Effects Of AER 002 On Mucociliary Clearance In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
入选标准
- •(a) Males or females diagnosed with chronic obstructive pulmonary disease;
- •(b)Aged >40 yrs
- •(c)Subjects who have an FEV1 of 75% or less of predicted at time of screening
- •(d)Subjects who, if female, are not currently pregnant or breast feeding and using medically acceptable methods of contraception, or are post-menopausal or surgically sterile.
- •(e)Subjects who have a pre-study medical history, physical examination, 12 Lead ECG acceptable to the Investigator.
- •(f)Subjects who are negative for HbsAg, hepatitis C antibody and HIV II and I test at screening.
- •(g)Subjects who are negative for drugs of abuse and alcohol tests at screening.
- •(h)Must be willing and able to participate in the whole study and must 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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(a)Subjects who have ever sought advice from a General Practitioner or counselor for abuse or misuse of alcohol, non-medical, medicinal drugs, or other substance abuse e.g. solvents.
- •(b)Positive drugs of abuse test result.
- •(c) Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator.
- •(d)Upper or lower respiratory tract infection (excluding otitis media) within 7 days of the first study day (Day 1 of dosing) (requiring antibiotics for that infection)
- •(e) Subjects who have had a change in their COPD medication in the 4 weeks prior to study entry
- •(f)Any other significant disease or condition which may interfere with the compound or outcome of the study e.g. metabolic conditions, renal, cardiac or hepatic conditions.
- •(g)Participation in a clinical research study in the past 3 months
- •(h)Subjects who use ambulatory oxygen >10 hours per day
- •(i)Subjects who have had past lung surgeries for COPD (excluding routine biopsies)
- •(j)Subjects who are currently taking tiotropium bromide (SPIRIVA®)
- •(k)Subjects who are currently not producing a lot of sputum in the opinion of the investigator
研究者
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