NCT07382258 A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease
| NCT ID | NCT07382258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novlead Inc. |
| Condition | Chronic Obstructive Pulmonary Disease (COPD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2023-05-17 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 16 participants in total. It began in 2023-05-17 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07382258 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Chronic Obstructive Pulmonary Disease (COPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07382258 currently recruiting?
Yes, NCT07382258 is actively recruiting participants. Contact the research team at chenxi.wu@novlead.com for enrollment information.
Where is the NCT07382258 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07382258 clinical trial?
NCT07382258 is sponsored by Novlead Inc.. The trial plans to enroll 16 participants.
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