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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 8
- 主要终点
- The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period.
研究概览
简要总结
The primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of AQX-1125 compared to placebo in subjects following exacerbations of Chronic Obstructive Pulmonary Disease (COPD) by targeting the SHIP1 (Src Homology 2-containing Inositol-5'-Phosphatase 1) pathway.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide. Acute exacerbations of COPD are usually treated with steroids and/or antibiotics. Currently this conventional therapy has significant side effects including osteoporosis, cataracts and suppression of the immune system (from the steroids) and increasing bacterial resistance and other side effects from the use of antibiotics. During an acute exacerbation of COPD, the inflammation in the airways increases.
AQX-1125 represents a new type drug that based current data is thought decrease the inflammatory process and therefore may provide a therapeutic benefit in the treatment of COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥40 years at screening
- •History of COPD for at least 18 months prior to screening, characterised by excessive sputum production
- •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
- •At least 2 documented exacerbations during the last 18 months prior to screening.
- •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
- •Ability to perform pulmonary function testing and with documented fixed airway obstruction determined by an FEV1 /FVC [forced vital capacity] ratio (post-bronchodilator) of <0.70 and a predicted FEV1 value of 30%-80% of normal within the 6 months prior to Visit
- •Former smoker or current smoker, both with a smoking history of at least 10 pack years
排除标准
- •Diagnosis of other relevant lung disease (e.g. asthma, cystic fibrosis [CF] or significant non-CF bronchiectasis)
- •Known alpha-1-antitrypsin deficiency
- •Treatment with roflumilast or theophylline within 1 month prior to screening
- •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
- •Hospitalisation for more than 7 days for current acute exacerbation, or the requirement for intubation during hospitalisation
- •For outpatients, prior medical history indicating that previous exacerbations required >3 weeks to stabilise
研究组 & 干预措施
AQX-1125
1 x AQX-1125 capsule daily
干预措施: AQX-1125 (Drug)
Placebo
1 x Placebo capsule daily
干预措施: Placebo (Drug)
结局指标
主要结局
The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period.
时间窗: 12 weeks
The primary variable (endpoint) of this study is the difference in the Area Above the Curve (AAC) for the daily EXACT score from baseline to Week 12 between subjects treated with AQX-1125 and placebo.The EXACT questionnaire is a patient reported outcome (PRO) measure designed to standardise the method for evaluating the frequency, severity and duration of acute exacerbations of COPD. The EXACT is a 14-item daily questionnaire where each item is assessed on a 5 or 6 point ordinal scale. Participants completed the EXACT questionnaire on a daily basis via an electronic diary from Day 1 (pre-dose) to Day 84 (week 12). Higher scores on the daily EXACT questionnaire indicate a more severe health state. When the post-treatment EXACT scores are lower (i.e. improved symptoms) than baseline EXACT, the AACs are positive.
次要结局
- Change From Baseline in COPD Assessment Tool (CAT) Score(12 weeks)
- Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE))(12 weeks)
- Time to First COPD Exacerbation(12 weeks)
- The Number of Subjects With at Least One COPD Exacerbation.(12 weeks)
- Change From Baseline in FEV1(12 weeks)
- AQX-1125 Concentrations in Plasma (Trough Values)(12 weeks)