Actively Recruiting
Efficacy and Safety of Inhaled Nitric Oxide for Moderate-to-Severe Chronic Obstructive Pulmonary Disease in a Prospective, Single-Center Clinical Trial
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-06-18
24
Participants Needed
1
Research Sites
25 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
Researchers are investigating the effects of inhaled nitric oxide (iNO) on exercise capacity and safety in people with moderate-to-severe chronic obstructive pulmonary disease (COPD). The study evaluates two doses of iNO, 10 parts per million (ppm) and 40 ppm, each administered for at least 2 hours daily over one week. This research aims to find safe and effective treatment methods for COPD, focusing on lung function and exercise performance. Participants are randomly assigned to one of three groups: inhaled nitric oxide at 10 ppm, inhaled nitric oxide at 40 ppm, or a placebo treatment using air. Each treatment is inhaled for at least 2 hours per day for 7 consecutive days. The iNO is delivered through a specialized system that ensures a constant concentration during inhalation. The placebo group inhales air with 21% oxygen, mimicking the treatment process without active nitric oxide. During the study, participants undergo cardiopulmonary exercise tests measuring oxygen uptake, ventilation efficiency, and breathlessness scores at the start and end of the 7-day treatment period. Lung function tests, symptom questionnaires, a six-minute walk test, and safety monitoring for adverse events are also performed. The study tracks changes from baseline to day 7 to assess the impact of the treatments on exercise capacity and respiratory health.
CONDITIONS
Brief 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 the study
- Diagnosed with moderate or severe COPD: post-bronchodilator FEV1/FVC ratio less than 0.7, and FEV1 between 30% and 80% of predicted
- Signed informed consent and completed all required study procedures
You will not qualify if you...
- Pregnant or breastfeeding women
- Current or recent use (within one month) of nicotine products such as patches
- Diagnosis of asthma or other non-COPD respiratory diseases
- Nasal passages not open on physical examination
- Recent exacerbation within the last month requiring increased oral corticosteroid treatment
- Left ventricular systolic dysfunction with ejection fraction less than 50%
- Significant heart valve diseases including moderate or severe aortic or mitral valve problems
- Use of approved pulmonary hypertension medications within 30 days before screening
- Use of investigational drugs or devices within 30 days prior to study enrollment
- Any other medical or psychiatric condition making the participant unsuitable for the study
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 days
Participants inhale either low concentration (10ppm) or high concentration (40ppm) nitric oxide, or placebo air, for at least 2 hours per day over 7 days.
Daily treatment sessions for 7 days with baseline and Day 7 assessments
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
L
Liuchao Zhang, Master
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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