Bronchodilator Properties and Safety in Asthma
Bronchodilator Properties and Safety of a Repeated Dose of V0162 in Asthma.
Recent large clinical studies have demonstrated the interest of LAMA therapy in the management of asthma, when compared to LABA.
V0162 is a compound with a very long lasting bronchodilator effect when compared to reference treatment in non-clinical models and in COPD patients. Secondary properties of V0162 (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic compound and could bring option in the treatment obstructive lung disease. The objective of the study is to assess the bronchodilator properties of V0162 during 8 days in adult patients with asthma usually treated with ICS and LABA. The study is a randomised, double-blind, placebo-controlled, 3-period crossover, preceded by an open-label active-control period before randomisation.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Gauting、德国
- cro
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 18 to 65 years-old.
- 18 ≤ BMI <30 kg/m².
- Clinical history consistent asthma, in the judgement of the investigator.
- Asthma controlled or partly controlled according to GINA 2012 criteria:
- Asthma treated by ICS and LABA (fixed-dose combination or free combination) at stable dose for at least 3 months.
- Able to replace the usual ICS and LABA therapy by ICS at the usual dose regimen and salbutamol as needed.
- Able to stop salbutamol at least 6 hours before a study visit.
- Able to perform at least 3 acceptable and reproducible FEV1 and FVC measurements according to ERS/ATS 2005 recommendations.
Exclusion Criteria:
- Clinically significant respiratory conditions other than asthma (e.g. pneumonia, pneumothorax, atelectasis, bronchiectasis, chronic bronchitis, COPD, emphysema, pulmonary arterial hypertension, pulmonary fibrosis,etc.).
- Upper or lower respiratory tract infection within 4 weeks.
- Exacerbation (requiring oral corticosteroids or hospitalization) within 3 months.
- Current smoker or former smoker less than 6 months or total lifetime smoking history greater than 10 pack-years.
- Intolerance to salbutamol.
- Intolerance to tiotropium (or any other atropine-derived compound).
- Intolerance to one of the ingredients of the study product
- Severe hepatic impairment, moderate to severe renal impairment, epilepsy, narrow angle glaucoma, gastrointestinal obstruction, moderate to severe prostatic hypertrophy, bladder neck obstruction.
- Any acute or chronic disease that will not allow the participation in the study, in the judgement of the investigator.
- Clinically relevant physical examination abnormality.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Normalised AUC 0-24h of FEV1 at day 8 of treatment period
大体时间:At the 8th day of treatment period
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FEV1 assessed by spirometry
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At the 8th day of treatment period
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Parameters of the pulmonary function
大体时间:Day 1 and Day 8 of treatment period
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as well as the following criteria assessed the first day and the last day of each treatment period and the difference between the last day and the first day within each treatment periodadjusted for placebo effect:
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Day 1 and Day 8 of treatment period
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PEF
大体时间:Morning and evening from Day 1 to day 8 of treatment period
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PEF measured using a peak-flow meter
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Morning and evening from Day 1 to day 8 of treatment period
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Dyspnoea
大体时间:Day 1 to Day 8 of treatment period
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The criteria will be the normalised AUC0-9h,AUC0-12h, and AUC0-24h of the dyspnoea measurements(mm) assessed the first and the last day of each treatment period, and the difference between the last and the first day within each treatment period.
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Day 1 to Day 8 of treatment period
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Vital signs
大体时间:Visit 2, and at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 24 h post-dose during the in-clinic visits) and at Visit 11
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Visit 2, and at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 24 h post-dose during the in-clinic visits) and at Visit 11
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12-lead standard ECG
大体时间:at Visit 1, at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 1 h, 6 h, 24 h post-dose) and at Visit 11
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at Visit 1, at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 1 h, 6 h, 24 h post-dose) and at Visit 11
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Holter-ECG
大体时间:At Visit 3 to Visit 10 : from 30 min pre-dose to 12 hours post-dose
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At Visit 3 to Visit 10 : from 30 min pre-dose to 12 hours post-dose
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Clinical laboratory tests (haematology, biochemistry, urinalysis)
大体时间:Visit 1 and Visit 11
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Visit 1 and Visit 11
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AEs
大体时间:From Visit 1 to Visit 11
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From Visit 1 to Visit 11
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Normalised AUC 0-24h of FEV1 at Day 1 of treatment period
大体时间:The first day of treatment period
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FEV1 assessed by spirometry
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The first day of treatment period
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Difference between day 8 and first day of treatment period in normalised AUC 0-24h of FEV1
大体时间:Difference between day 8 and first day of treatement period
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FEV1 assessed by spirometry
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Difference between day 8 and first day of treatement period
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的