Chronic Obstructive Pulmonary Disease Clinical Trial
— NOVELOfficial title:
Efficacy and Safety of Inhaled Nitric Oxide in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease: a Prospective, Single-center Clinical Trial
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.
Status | Recruiting |
Enrollment | 16 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Age = 40 years, = 75 years; 2. Previous smoking history = 10 pack-years, and had stopped smoking for one month before study entry; 3. Met the diagnosis criteria of moderate and severe COPD: a post-bronchodilator FEV1/FVC < 0.7, and 30%< FEV1 < 80% predicted; 4. Signed informed consent and performed all the study mandated procedures. Exclusion Criteria: 1. Pregnant or lactating women; 2. Current or recent month user of nicotine-like substances (including nicotine patches, etc.); 3. A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator; 4. Lack of patency of nares upon physical examination; 5. Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy; 6. Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) < 50%; 7. 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; 8. Use within 30 days of screening or current use of approved pulmonary hypertension medications such as sildenafil, bosentan or prostacyclines; 9. Use of investigational drugs or devices within 30 days prior to enrollment into the study; 10. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University | Novlead Inc. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiopulmonary Exercise Test: Maximal oxygen uptake(VO2max) | Change in VO2max from Baseline after treatment with iNO | Baseline, Day 7 | |
Primary | Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output(VE/VCO2) | Change in VE/VCO2 from Baseline after treatment with iNO | Baseline, Day 7 | |
Primary | Cardiopulmonary Exercise Test: Borg score | Change in Borg score from Baseline after treatment with iNO | Baseline, Day 7 | |
Primary | Cardiopulmonary Exercise Test: oxygen uptake/work (?VO2/?W) ratio | Change in ?VO2/?W ratio from Baseline after treatment with iNO | Baseline, Day 7 | |
Secondary | Pulmonary function:Forced expiratory volume in 1 second(FEV1) | Change in FEV1 from Baseline after treatment with iNO | Baseline, Day 7 | |
Secondary | Pulmonary function: Forced vital capacity (FVC) | Change in FVC from Baseline after treatment with iNO | Baseline, Day 7 | |
Secondary | Pulmonary function:FEV1/FVC | Change in FEV1/FVC from Baseline after treatment with iNO | Baseline, Day 7 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Six-minute walk test | Change in exercise capacity from Baseline after treatment with iNO: the distance of six-minute walk test | Baseline, Day 7 | |
Secondary | Adverse events | Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100% | Baseline up to Day 7 |
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