NCT01951222已完成2 期
Bronchodilator Properties and Safety of a Repeated Dose of V0162 in Asthma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Normalised AUC 0-24h of FEV1 at day 8 of treatment period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
V0162 dose1
Experimental
干预措施: V0162 (Drug)
V0162 dose2
Experimental
干预措施: V0162 (Drug)
placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Normalised AUC 0-24h of FEV1 at day 8 of treatment period
时间窗: At the 8th day of treatment period
FEV1 assessed by spirometry
次要结局
- 12-lead standard ECG(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)
- Holter-ECG(At Visit 3 to Visit 10 : from 30 min pre-dose to 12 hours post-dose)
- AEs(From Visit 1 to Visit 11)
- Difference between day 8 and first day of treatment period in normalised AUC 0-24h of FEV1(Difference between day 8 and first day of treatement period)
- PEF(Morning and evening from Day 1 to day 8 of treatment period)
- Vital signs(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)
- Parameters of the pulmonary function(Day 1 and Day 8 of treatment period)
- Clinical laboratory tests (haematology, biochemistry, urinalysis)(Visit 1 and Visit 11)
- Normalised AUC 0-24h of FEV1 at Day 1 of treatment period(The first day of treatment period)
- Dyspnoea(Day 1 to Day 8 of treatment period)
研究者
研究点 (1)
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