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| Name | Class |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iNO 10 ppm Dose Group | Experimental | Participants will receive inhaled nitric oxide at a concentration of 10 ppm, for a minimum of 2 hours per day, over 7 consecutive days. |
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| iNO 40 ppm Dose Group | Experimental | Participants will receive inhaled nitric oxide at a concentration of 40 ppm, for a minimum of 2 hours per day, over 7 consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide Generation and Delivery System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maximal Oxygen Uptake (VO2max) | The difference in VO2max values measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period. | 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. | 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. | 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. | Baseline, Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 7 |
| Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Proportion of participants experiencing any adverse event during the treatment period, calculated as (Number of subjects with adverse events / Total number of treated subjects) * 100%. | Baseline up to Day 7 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenxi Wu, Master | Contact | +8615850568410 | chenxi.wu@novlead.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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. |
| Baseline, Day 7 |
| 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. | 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. | 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. | 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. | Baseline, Day 7 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |