Efficacy and Safety of Inhaled Nitric Oxide in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease: a Prospective, Single-center Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cardiopulmonary Exercise Test: Borg score
研究概览
简要总结
The purpose of this study is to evaluate the influence of exercise capacity and safety of iNO at doses of 10 ppm or 40 ppm for 2 hours per day after continuous treatment for one week, which is of great significance for finding safe and effective methods for treating 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
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years, ≤ 75 years;
- •Previous smoking history ≥ 10 pack-years, and had stopped smoking for one month before study entry;
- •Met the diagnosis criteria of moderate and severe COPD: a post-bronchodilator FEV1/FVC < 0.7, and 30%< FEV1 < 80% predicted;
- •Signed informed consent and performed all the study mandated procedures.
排除标准
- •Pregnant or lactating women;
- •Current or recent month user of nicotine-like substances (including nicotine patches, etc.);
- •A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator;
- •Lack of patency of nares upon physical examination;
- •Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy;
- •Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) < 50%;
- •Clinically significant valvular heart disease, including aortic valvular disease (moderate or severe aortic stenosis or regurgitation) and/or mitral valve disease (moderate or severe mitral stenosis or regurgitation), or status post mitral valve replacement;
- •Use within 30 days of screening or current use of approved pulmonary hypertension medications such as sildenafil, bosentan or prostacyclines;
- •Use of investigational drugs or devices within 30 days prior to enrollment into the study;
- •Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study.
结局指标
主要结局
Cardiopulmonary Exercise Test: Borg score
时间窗: Baseline, Day 7
Change in Borg score from Baseline after treatment with iNO
Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output（VE/VCO2）
时间窗: Baseline, Day 7
Change in VE/VCO2 from Baseline after treatment with iNO
Cardiopulmonary Exercise Test: Maximal oxygen uptake（VO2max）
时间窗: Baseline, Day 7
Change in VO2max from Baseline after treatment with iNO
Cardiopulmonary Exercise Test: oxygen uptake/work (△VO2/△W) ratio
时间窗: Baseline, Day 7
Change in △VO2/△W ratio from Baseline after treatment with iNO
次要结局
- Adverse events(Baseline up to Day 7)
- Life quality and symptom severity questionnaires: COPD assessment test (CAT)(Baseline, Day 7)
- Pulmonary function：FEV1/FVC(Baseline, Day 7)
- Life quality and symptom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale(Baseline, Day 7)
- Pulmonary function:Forced expiratory volume in 1 second（FEV1）(Baseline, Day 7)
- Pulmonary function: Forced vital capacity （FVC）(Baseline, Day 7)
- Six-minute walk test(Baseline, Day 7)