Metformin IN Asthma for Overweight and Obese Individuals (MINA)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Adherence to study drug
研究概览
简要总结
This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.
详细描述
This is a randomized, placebo-controlled, parallel-arm pilot clinical trial. Adult participants who are overweight or obese and have not well-controlled asthma despite use of an inhaled corticosteroid will be randomized to metformin, an FDA-approved medication for the treatment of type 2 diabetes mellitus, or to placebo, to be taken daily for a total duration of six months. Recruitment will occur at two sites in the United States.
Randomized participants will have regular telemedicine visits to assess side effects and adherence. Additionally, participants will have a measurement of asthma outcomes at randomization and at 3 and 6 months after randomization.
The purpose of this study is to determine feasibility to inform a future multi-center clinical trial of metformin in this population.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed asthma on maintenance therapy
- •Not well-controlled asthma (ACT score <20, or at least one asthma exacerbation requiring corticosteroids in the prior 12 months)
- •Overweight or obesity: Body mass index ≥25kg/m2
- •Adult: Age ≥18
排除标准
- •Currently pregnant, expect to become pregnant in the next 6 months or are currently breastfeeding
- •Major cardiovascular disease: heart failure, heart attack or stroke within the last 6 months
- •Other chronic lung disease, inclusive of chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, pulmonary fibrosis
- •Active smoking or former smoker with ≥20 pack-year smoking history
- •Chronic kidney disease: estimated glomerular filtration rate ≤60 mL/min/1.73 m2
- •Heavy alcohol use: in a typical week, 8 or more drinks for a woman or 15 or more drinks for a man
- •Liver disease: elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x the upper limit of normal or prior diagnosis of liver disease
- •Anemia: hemoglobin < 13 g/dl in males and hemoglobin < 11 g/dl in females
- •Taking Glucagon Like Peptide 1(GLP-1) medications for weight loss
- •Diabetes (Hemoglobin A1C ≥ 6.5% or taking metformin or other medications used to treat diabetes)
- •Participation in any other clinical trial (observational studies are permitted)
研究组 & 干预措施
Metformin hydrochloride extended-release tablets
Metformin hydrochloride extended-release tablets 2000 mg once daily
干预措施: Metformin hydrochloride extended-release tablets (Drug)
Visually identical placebo tablets
Placebo tablet once daily
干预措施: Visually identical placebo Metformin hydrochloride extended-release tablets (Drug)
结局指标
主要结局
Adherence to study drug
时间窗: Baseline to week 24
Adherence will be measured by pill count
Number of completed telemedicine visits
时间窗: Baseline to week 24
Number of participants completing at least 3 out of the 4 monitoring telemedicine visits
Retention rate
时间窗: Baseline to week 24
Investigators will collect data on the number of subjects screened, randomized, and complete the final in-person visit
次要结局
- Asthma control as assessed by the Asthma Control Test (ACT) score(Baseline to week 24)
- Change in Asthma exacerbations rate(Baseline to week 24)
- Fractional exhaled nitric oxide (FeNO)(Baseline to week 24)
- Pre-bronchodilator lung function(Baseline to week 24)
- Airways hyperresponsiveness(Baseline to week 24)