Efficacy and Safety of Inhaled Nitric Oxide in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease: a Prospective, Single-center Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:
• Age ≥ 40 years, ≤ 75 years;
• Previous smoking history ≥ 10 pack-years, and had stopped smoking for one month before study entry;
• Met the diagnosis criteria of moderate and severe COPD: a post-bronchodilator FEV1/FVC \< 0.7, and 30%\< FEV1 \< 80% predicted;
• Signed informed consent and performed all the study mandated procedures.
Locations
Other Locations
China
The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Linfu Zhou, Doctor
linfu.zhou@126.com
+8613611573618
Backup
Liuchao Zhang, Master
+8615850423930
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 24
Treatments
Experimental: Low concentration group
inhaled nitric oxide (iNO) 10ppm，≥2 hours/day for 7 days
Experimental: High concentration group
iNO 40ppm，≥2 hours/day for 7 days
Placebo_comparator: Placebo group
patient inhaled placebo treatment
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University
Collaborators: Novlead Inc.