What is inhaled nitric oxide studying for chronic obstructive pulmonary disease?

This study is examining how inhaled nitric oxide at two different doses affects exercise capacity and safety in people with moderate-to-severe COPD. Researchers want to find safe and effective ways to improve breathing and physical activity. The study is sponsored by The First Affiliated Hospital with Nanjing Medical University.

Who may be eligible for this chronic obstructive pulmonary disease clinical trial?

Adults aged 40 to 75 years with a history of smoking and diagnosed moderate-to-severe COPD may be eligible. Both men and women can participate, but pregnant or breastfeeding women are excluded. Other factors include not using nicotine products recently and having no other serious heart or lung diseases. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic obstructive pulmonary disease clinical trial?

Study-related care, including the study treatments and all trial visits, is provided at no cost. Personal expenses such as travel may vary and might not be covered. Participants should plan accordingly for any transportation or accommodation costs.

Actively Recruiting

Phase Not Applicable

Age: 40Years - 75Years

All Genders

ID05896800

Study of Inhaled Nitric Oxide Treatment for Adults Aged 40 to 75 With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-06-18

Participants Needed

Research Sites

25 weeks

Total Duration

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

Age: 40Years - 75Years

All Genders

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

Research Team

Linfu Zhou, Doctor

Liuchao Zhang, Master

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