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| Name | Class |
|---|---|
| Novlead Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low concentration group | Experimental | inhaled nitric oxide (iNO) 10ppm,≥2 hours/day for 7 days |
|
| High concentration group | Experimental | iNO 40ppm,≥2 hours/day for 7 days |
|
| Placebo group | Placebo Comparator | patient inhaled placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled nitric oxide (NO) | Other | The Nitric Oxide Generation and Delivery System is used to deliver nitric oxide for inhalation therapy into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiopulmonary Exercise Test: Maximal oxygen uptake(VO2max) | Change in VO2max from Baseline after treatment with iNO | Baseline, Day 7 |
| Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output(VE/VCO2) | Change in VE/VCO2 from Baseline after treatment with iNO | Baseline, Day 7 |
| Cardiopulmonary Exercise Test: Borg score | Change in Borg score from Baseline after treatment with iNO | Baseline, Day 7 |
| Cardiopulmonary Exercise Test: oxygen uptake/work (△VO2/△W) ratio | Change in △VO2/△W ratio from Baseline after treatment with iNO | Baseline, Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function:Forced expiratory volume in 1 second(FEV1) | Change in FEV1 from Baseline after treatment with iNO | Baseline, Day 7 |
| Pulmonary function: Forced vital capacity (FVC) | Change in FVC from Baseline after treatment with iNO |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linfu Zhou, Doctor | Contact | +8613611573618 | linfu.zhou@126.com | |
| Liuchao Zhang, Master | Contact | +8615850423930 |
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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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| ID | Term |
|---|---|
| D000388 | Air |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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|
| air | Other | use air(21%O2)as the placebo of inhaled treatment |
|
| Baseline, Day 7 |
| Pulmonary function:FEV1/FVC | Change in FEV1/FVC from Baseline after treatment with iNO | Baseline, Day 7 |
| Life quality and symptom severity questionnaires: COPD assessment test (CAT) | Change in CAT scores (0-40 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO | Baseline, Day 7 |
| Life quality and symptom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale | Change in (mMRC) Dyspnea Scale scores (0-4 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO | Baseline, Day 7 |
| Six-minute walk test | Change in exercise capacity from Baseline after treatment with iNO: the distance of six-minute walk test | Baseline, Day 7 |
| Adverse events | Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100% | Baseline up to Day 7 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |