A Prospective, Single-Center Study of Inhaled Nitric Oxide in Individuals Diagnosed With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Novlead Inc.
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Maximal Oxygen Uptake (VO2max)
研究概览
简要总结
This clinical trial aims to assess the impact on exercise tolerance and the safety of inhaled nitric oxide in subjects with moderate-to-severe COPD. The findings are expected to contribute to the development of safe and effective therapeutic strategies for COPD management.
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
- •Aged between 40 and 75 years, inclusive.
- •History of smoking with a cumulative exposure of ≥10 pack-years, and having ceased smoking for at least one month prior to study participation.
- •Diagnosis of moderate-to-severe COPD confirmed by post-bronchodilator spirometry: FEV1/FVC < 0.7 and FEV1 between 30% and 80% of predicted value.
- •Willing and able to provide written informed consent and comply with all study-related procedures.
排除标准
- •Pregnancy or lactation.
- •Use of nicotine-containing products (e.g., patches, gum) within the past month.
- •Current diagnosis of asthma or any other active respiratory condition considered non-COPD by the investigator.
- •Physical obstruction of the nasal passages.
- •Experienced a COPD exacerbation within the past month requiring initiation or escalation of systemic corticosteroids.
- •Impaired left ventricular systolic function, defined as left ventricular ejection fraction (LVEF) < 50%.
- •Significant valvular heart disease (moderate/severe aortic or mitral stenosis/regurgitation) or prior mitral valve replacement.
- •Use of approved pulmonary hypertension medications (e.g., sildenafil, bosentan, prostacyclins) within 30 days prior to screening or during the study.
- •Participation in another interventional clinical trial involving drugs or devices within 30 days prior to enrollment.
- •Any other medical or psychiatric condition that, in the investigator's judgment, would compromise patient safety or study integrity.
研究组 & 干预措施
iNO 10 ppm Dose Group
Participants will receive inhaled nitric oxide at a concentration of 10 ppm, for a minimum of 2 hours per day, over 7 consecutive days.
干预措施: Nitric Oxide Generation and Delivery System (Device)
iNO 40 ppm Dose Group
Participants will receive inhaled nitric oxide at a concentration of 40 ppm, for a minimum of 2 hours per day, over 7 consecutive days.
干预措施: Nitric Oxide Generation and Delivery System (Device)
结局指标
主要结局
Change in Maximal Oxygen Uptake (VO2max)
时间窗: Baseline, Day 7
The difference in VO2max values measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
Change in Ventilatory Efficiency (VE/VCO2)
时间窗: Baseline, Day 7
The difference in the minute ventilation-to-carbon dioxide output (VE/VCO2) ratio measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
Change in Oxygen Uptake to Work Rate Ratio (ΔVO2/ΔW)
时间窗: Baseline, Day 7
The difference in the ratio of change in oxygen uptake to change in work rate (ΔVO2/ΔW) measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
Change in Perceived Exertion (Borg Score)
时间窗: Baseline, Day 7
The difference in Borg scale scores for perceived exertion recorded during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
次要结局
- Change in COPD Assessment Test (CAT) Score(Baseline, Day 7)
- Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score(Baseline, Day 7)
- Change in Six-Minute Walk Distance (6MWD)(Baseline, Day 7)
- Change in Forced Expiratory Volume in 1 Second (FEV1)(Baseline, Day 7)
- Change in Forced Vital Capacity (FVC)(Baseline, Day 7)
- Change in FEV1/FVC Ratio(Baseline, Day 7)