EUCTR2013-001951-11-FI进行中（未招募）1 期
The FLAGSHIP Study: A 12-week Phase II Study to Evaluate the Efficacy and Safety of AQX-1125 Following Exacerbations in Patients with Chronic Obstructive Pulmonary Disease (COPD) by Targeting the SHIP1 Pathway - FLAGSHIP: AQX-1125 in patients with exacerbations of COPD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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. Provide written informed consent and be willing and able to comply with all aspects of the study requirements
- •2. Male or female aged =40 years at screening
- •3. History of COPD for at least 18 months prior to screening, characterised by excessive sputum production
- •4. Chronic productive cough for at least 3 months in each of the 2 years prior to screening (if other causes of productive cough have been excluded) and/or an exacerbation of COPD with predominantly bronchitic symptoms at enrolment
- •5. At least 2 documented exacerbations during the last 18 months prior to screening.
- •If the subject has experienced exacerbations during the last 18 months that were self-treated at home and subsequently documented by a physician, this can be documented at Visit 1
- •6. Presentation of a diagnosed acute exacerbation of COPD, or have recently (within 3 days) been discharged from hospital due to an acute exacerbation of COPD
- •7. Ability to perform pulmonary function testing and with documented fixed airway obstruction determined by an FEV1 /forced vital capacity (FVC) ratio (post-bronchodilator) of <0.70 and a predicted FEV1 value of 30%-80% of normal within the 6 months prior to or at Visit 1.
- •8. Former smoker or current smoker, both with a smoking history of at least 10 pack years
- •9. Female subjects should be of non-child bearing potential. They should be one year or more post-menopause, previously surgically sterilised, or have had a hysterectomy. From the screening visit until 1 month after last dose of investigational medicinal product (IMP), male subjects must agree to use condoms with any sexual intercourse with women of child bearing potential and have partners who use adequate methods of contraception (e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, or combination birth control pills). If male subjects have had a confirmed vasectomy use of condoms is not required.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Diagnosis of other relevant lung disease (e.g. asthma, cystic fibrosis [CF] or significant non-CF bronchiectasis)
- •2. Known alpha-1-antitrypsin deficiency
- •3. Treatment with roflumilast or theophylline within 1 month prior to screening
- •4. History of alcohol or drug abuse in the past 3 years prior to screening
- •5. Participation in another clinical research study within 90 days prior to screening
- •6. Lobar pneumonia, with current positive chest X-ray (CXR) or within the 3 months prior to screening including the presence of any new radiological infiltrate on CXR within the previous two weeks
- •7. Have any other conditions, disease or circumstances which, in the opinion of the Investigator, could compromise safety of the subject or confound the interpretation of the study results. This will include a relevant documented medical history of clinically significant irregularities in kidney function, liver function or blood counts; or malignant or premalignant irregularities of the urinary bladder.
- •8. Serious and/or life-threatening co-existing conditions that would merit acute hospitalisation, aside from the acute exacerbation event
- •These include, but are not limited to, acute myocardial infarction, acute renal failure, acute pancreatitis, thromboembolic disease, and diabetic ketoacidosis
- •9. Hospitalisation for more than 7 days for current acute exacerbation, or the requirement for intubation during hospitalisation
- •10. For outpatients, prior medical history indicating that previous exacerbations required >3 weeks to stabilise
- •11. Known intolerance to micro-crystalline cellulose (Avicel® PH-102)
研究者
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