NOVEL: A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low concentration group inhaled nitric oxide (iNO) 10ppm，≥2 hours/day for 7 days |
Device: Nitric Oxide Generation and Delivery System
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.
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| Experimental: High concentration group iNO 40ppm，≥2 hours/day for 7 days |
Device: Nitric Oxide Generation and Delivery System
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.
|
Outcome Measures
Primary Outcome Measures
- Cardiopulmonary Exercise Test: Maximal oxygen uptake（VO2max） [Baseline, Day 7]
Change in VO2max from Baseline after treatment with iNO
- Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output（VE/VCO2） [Baseline, Day 7]
Change in VE/VCO2 from Baseline after treatment with iNO
- Cardiopulmonary Exercise Test: Borg score [Baseline, Day 7]
Change in Borg score from Baseline after treatment with iNO
- Cardiopulmonary Exercise Test: oxygen uptake/work (△VO2/△W) ratio [Baseline, Day 7]
Change in △VO2/△W ratio from Baseline after treatment with iNO
Secondary Outcome Measures
- Pulmonary function:Forced expiratory volume in 1 second（FEV1） [Baseline, Day 7]
Change in FEV1 from Baseline after treatment with iNO
- Pulmonary function: Forced vital capacity （FVC） [Baseline, Day 7]
Change in FVC from Baseline after treatment with iNO
- Pulmonary function：FEV1/FVC [Baseline, Day 7]
Change in FEV1/FVC from Baseline after treatment with iNO
- Life quality and symptom severity questionnaires: COPD assessment test (CAT) [Baseline, Day 7]
Change in CAT scores (0-40 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO
- Life quality and symptom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale [Baseline, Day 7]
Change in (mMRC) Dyspnea Scale scores (0-4 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO
- Six-minute walk test [Baseline, Day 7]
Change in exercise capacity from Baseline after treatment with iNO: the distance of six-minute walk test
- Adverse events [Baseline up to Day 7]
Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100%
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 40 years, ≤ 75 years;
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Previous smoking history ≥ 10 pack-years, and had stopped smoking for one month before study entry;
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Met the diagnosis criteria of moderate and severe COPD: a post-bronchodilator FEV1/FVC < 0.7, and 30%< FEV1 < 80% predicted;
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Signed informed consent and performed all the study mandated procedures.
Exclusion Criteria:
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Pregnant or lactating women;
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Current or recent month user of nicotine-like substances (including nicotine patches, etc.);
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A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator;
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Lack of patency of nares upon physical examination;
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Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy;
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Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) < 50%;
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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;
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Use within 30 days of screening or current use of approved pulmonary hypertension medications such as sildenafil, bosentan or prostacyclines;
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Use of investigational drugs or devices within 30 days prior to enrollment into the study;
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Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The First Affiliated Hospital with Nanjing Medical University
- Novlead Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-COPD-002