Actively Recruiting
A Prospective, Single-Center Study of Inhaled Nitric Oxide in Individuals Diagnosed With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Led by Novlead Inc. · Updated on 2026-02-02
16
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating inhaled nitric oxide to understand its effects on exercise tolerance and safety in people with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). This study aims to help develop better treatment options for managing COPD symptoms and improving patient outcomes. The trial is sponsored by Novlead Inc. and does not involve a specific drug phase classification. Participants will be randomly assigned to receive inhaled nitric oxide at either 10 parts per million (ppm) or 40 ppm. Each participant will inhale the gas for at least 2 hours each day over a period of 7 consecutive days. The nitric oxide is delivered using a specialized device that controls the concentration of gas inhaled through the breathing apparatus. During the study, participants will be closely monitored with various tests and assessments. These include measuring changes in oxygen uptake, breathing efficiency, perceived exertion, lung function, walking distance, and COPD symptom scores, all recorded at the beginning and end of the 7-day treatment period. Safety and treatment effects will be assessed throughout, with the total participation lasting just over one week.
CONDITIONS
Brief 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 at least 10 pack-years and stopped smoking for at least one month before participation
- Diagnosis of moderate-to-severe COPD confirmed by lung function tests showing FEV1/FVC less than 0.7 and FEV1 between 30% and 80% of predicted
- Willing and able to provide written informed consent and comply with study procedures
You will not qualify if you...
- Pregnancy or breastfeeding
- Use of nicotine-containing products within the past month
- Current diagnosis of asthma or other active lung conditions besides COPD
- Physical blockage of nasal passages
- COPD worsening in the past month needing increased steroid treatment
- Impaired left heart function with ejection fraction below 50%
- Significant heart valve disease or prior mitral valve replacement
- Use of pulmonary hypertension drugs within 30 days before screening or during the study
- Participation in another drug or device trial within 30 days before enrollment
- Any other medical or psychiatric condition that may affect safety or study integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 consecutive days
Participants receive inhaled nitric oxide therapy at either 10 ppm or 40 ppm dose for a minimum of 2 hours per day over 7 consecutive days using the nitric oxide delivery device.
Daily visits or monitoring during the 7-day treatment period
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
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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