Actively Recruiting
A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease
Led by Novlead Inc. · Updated on 2026-02-02
16
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
N
Novlead Inc.
Lead Sponsor
T
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 40 and 75 years, inclusive.
- History of smoking with a cumulative exposure of 6510 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
C
Chenxi Wu, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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