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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
A device designed to deliver a stable, user-prescribed concentration of nitric oxide gas into the inspiratory circuit of the patient's breathing apparatus for inhalation therapy.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGChange in Maximal Oxygen Uptake (VO2max)
The difference in VO2max values measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
Time frame: Baseline, Day 7
Change in Ventilatory Efficiency (VE/VCO2)
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.
Time frame: Baseline, Day 7
Change in Oxygen Uptake to Work Rate Ratio (ΔVO2/ΔW)
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.
Time frame: Baseline, Day 7
Change in Perceived Exertion (Borg Score)
The difference in Borg scale scores for perceived exertion recorded during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
Time frame: Baseline, Day 7
Change in COPD Assessment Test (CAT) Score
The difference in total CAT score (range 0-40, higher scores indicate worse health status) reported before and after the one-week iNO treatment period.
Time frame: Baseline, Day 7
Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score
The difference in mMRC dyspnea scale score (range 0-4, higher scores indicate greater breathlessness) reported before and after the one-week iNO treatment period.
Time frame: Baseline, Day 7
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Change in Six-Minute Walk Distance (6MWD)
The difference in the distance walked during a six-minute walk test performed before and after the one-week iNO treatment period.
Time frame: Baseline, Day 7
Change in Forced Expiratory Volume in 1 Second (FEV1)
The difference in FEV1 values from pulmonary function tests performed before and after the one-week iNO treatment period.
Time frame: Baseline, Day 7
Change in Forced Vital Capacity (FVC)
The difference in FVC values from pulmonary function tests performed before and after the one-week iNO treatment period.
Time frame: Baseline, Day 7
Change in FEV1/FVC Ratio
The difference in the FEV1/FVC ratio from pulmonary function tests performed before and after the one-week iNO treatment period.
Time frame: Baseline, Day 7