Status:
RECRUITING
A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Novlead Inc.
Collaborating Sponsors:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-75 years
Phase:
NA
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 deve...
Eligibility Criteria
Inclusion Criteria:
- Aged between 40 and 75 years, inclusive.
- History of smoking with a cumulative exposure of ≥10 pack-years, and having ceased smoking for at least one month prior to study participation.
- Diagnosis of moderate-to-severe COPD confirmed by post-bronchodilator spirometry: FEV1/FVC < 0.7 and FEV1 between 30% and 80% of predicted value.
- Willing and able to provide written informed consent and comply with all study-related procedures.
Exclusion Criteria:
- Pregnancy or lactation.
- Use of nicotine-containing products (e.g., patches, gum) within the past month.
- Current diagnosis of asthma or any other active respiratory condition considered non-COPD by the investigator.
- Physical obstruction of the nasal passages.
- Experienced a COPD exacerbation within the past month requiring initiation or escalation of systemic corticosteroids.
- Impaired left ventricular systolic function, defined as left ventricular ejection fraction (LVEF) < 50%.
- Significant valvular heart disease (moderate/severe aortic or mitral stenosis/regurgitation) or prior mitral valve replacement.
- Use of approved pulmonary hypertension medications (e.g., sildenafil, bosentan, prostacyclins) within 30 days prior to screening or during the study.
- Participation in another interventional clinical trial involving drugs or devices within 30 days prior to enrollment.
- Any other medical or psychiatric condition that, in the investigator's judgment, would compromise patient safety or study integrity.
Key Trial Info
Start Date :
May 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT07382258
Start Date
May 17 2023
End Date
April 30 2026
Last Update
February 2 2026
Active Locations (1)
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1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000