Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Sweat chloride
研究概览
简要总结
The goal of this clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy.
Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function.
详细描述
This is a randomized, placebo-controlled, parallel group clinical trial in those those with CF on elexacaftor/tezacaftor/ivacaftor to determine if treatment with losartan improves response to modulator therapy using sweat chloride as an marker of CFTR function.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of cystic fibrosis
- •Age 12 years and older
- •Stable use of elexacaftor/tezacaftor/ivacaftor for 90 days prior to enrollment
- •Sweat chloride concentration 50 mmol/L or greater while on elexacaftor/tezacaftor/ivacaftor
排除标准
- •Prior lung transplant
- •CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
- •Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
- •Chronic use of angiotensin receptor blockers or angiotensin converting enzyme inhibitors
- •Concomitant use of medications known to interact with losartan, including aliskiren
- •Chronic renal insufficiency (creatinine clearance <45 ml/min)
- •Pregnancy or lactation
- •Inability or unwillingness to comply with approved contraceptive method during the study period (females of childbearing age)
- •In the opinion of the investigator any severe or acute or chronic condition or laboratory abnormality that may increase the risk associated with trial participation or make the participant inappropriate for enrollment
- •Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome
研究组 & 干预措施
Losartan
Losartan 25mg twice daily for one week followed by 50mg twice daily through week 12.
干预措施: Losartan (Drug)
Placebo
Placebo twice daily through week 12
干预措施: Placebo (Drug)
结局指标
主要结局
Sweat chloride
时间窗: Baseline through week 12
Change in sweat chloride concentration
次要结局
- Inflammatory mediators - systemic(Baseline through week 12)
- CFQ-R(Baseline through week 12)
- Adverse events(Baseline through week 12)
- Lung function - absolute(Baseline through week 12)
- Lung function - relative(Baseline through week 12)
- TGF-beta1 - systemic(Baseline through week 12)
- Transforming growth factor (TGF)-beta1 - airway(Baseline through week 12)
- Inflammatory mediators - airway(Baseline through week 12)