Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD
Brief summary
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.
Interventions
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.
Sponsors
Novlead Inc.
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 40 and 75 years, inclusive. 2. History of smoking with a cumulative exposure of ≥10 pack-years, and having ceased smoking for at least one month prior to study participation. 3. Diagnosis of moderate-to-severe COPD confirmed by post-bronchodilator spirometry: FEV1/FVC \< 0.7 and FEV1 between 30% and 80% of predicted value. 4. Willing and able to provide written informed consent and comply with all study-related procedures.
Exclusion criteria
1. Pregnancy or lactation. 2. Use of nicotine-containing products (e.g., patches, gum) within the past month. 3. Current diagnosis of asthma or any other active respiratory condition considered non-COPD by the investigator. 4. Physical obstruction of the nasal passages. 5. Experienced a COPD exacerbation within the past month requiring initiation or escalation of systemic corticosteroids. 6. Impaired left ventricular systolic function, defined as left ventricular ejection fraction (LVEF) \< 50%. 7. Significant valvular heart disease (moderate/severe aortic or mitral stenosis/regurgitation) or prior mitral valve replacement. 8. Use of approved pulmonary hypertension medications (e.g., sildenafil, bosentan, prostacyclins) within 30 days prior to screening or during the study. 9. Participation in another interventional clinical trial involving drugs or devices within 30 days prior to enrollment. 10. Any other medical or psychiatric condition that, in the investigator's judgment, would compromise patient safety or study integrity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximal Oxygen Uptake (VO2max) | Baseline, Day 7 | The difference in VO2max values measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period. |
| Change in Ventilatory Efficiency (VE/VCO2) | Baseline, Day 7 | 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. |
| Change in Oxygen Uptake to Work Rate Ratio (ΔVO2/ΔW) | Baseline, Day 7 | 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. |
| Change in Perceived Exertion (Borg Score) | Baseline, Day 7 | The difference in Borg scale scores for perceived exertion recorded during cardiopulmonary exercise testing before and after the one-week iNO treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in COPD Assessment Test (CAT) Score | Baseline, Day 7 | 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. |
| Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score | Baseline, Day 7 | 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. |
| Change in Six-Minute Walk Distance (6MWD) | Baseline, Day 7 | The difference in the distance walked during a six-minute walk test performed before and after the one-week iNO treatment period. |
| Change in Forced Expiratory Volume in 1 Second (FEV1) | Baseline, Day 7 | The difference in FEV1 values from pulmonary function tests performed before and after the one-week iNO treatment period. |
| Change in Forced Vital Capacity (FVC) | Baseline, Day 7 | The difference in FVC values from pulmonary function tests performed before and after the one-week iNO treatment period. |
| Change in FEV1/FVC Ratio | Baseline, Day 7 | The difference in the FEV1/FVC ratio from pulmonary function tests performed before and after the one-week iNO treatment period. |
Countries
China
Contacts
CONTACTChenxi Wu, Master
Outcome results
None listed