Actively Recruiting
A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-06-18
24
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
N
Novlead Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 to 75 years
- Previous smoking history of at least 10 pack-years and stopped smoking for at least one month before study entry
- Diagnosis of moderate or severe COPD with post-bronchodilator FEV1/FVC less than 0.7 and FEV1 between 30% and 80% predicted
- Signed informed consent and completed all required study procedures
You will not qualify if you...
- Pregnant or lactating women
- Current or recent (within one month) use of nicotine-like substances such as nicotine patches
- Diagnosis of asthma or other non-COPD respiratory diseases as judged by the Investigator
- Blocked or non-patent nostrils on physical examination
- COPD exacerbation in the last month requiring start or increase of systemic oral corticosteroids
- Left ventricular ejection fraction less than 50%
- Significant valvular heart disease including moderate or severe aortic or mitral valve disease or history of mitral valve replacement
- Use of approved pulmonary hypertension medications like sildenafil, bosentan, or prostacyclines within 30 days before screening or current use
- Use of investigational drugs or devices within 30 days before enrollment
- Any other medical or psychiatric condition that makes participation unsuitable in the Investigator's opinion
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
L
Linfu Zhou, Doctor
CONTACT
L
Liuchao Zhang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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