A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Nitric Oxide Generation and Delivery System

• Registration Number: NCT05896800
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-01
• Study Start: 2023-06-07
• Study First Posted: 2023-06-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Age ≥ 40 years, ≤ 75 years;
2. Previous smoking history ≥ 10 pack-years, and had stopped smoking for one month before study entry;
3. Met the diagnosis criteria of moderate and severe COPD: a post-bronchodilator FEV1/FVC < 0.7, and 30%< FEV1 < 80% predicted;
4. Signed informed consent and performed all the study mandated procedures.

Exclusion Criteria

1. Pregnant or lactating women;
2. Current or recent month user of nicotine-like substances (including nicotine patches, etc.);
3. A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator;
4. Lack of patency of nares upon physical examination;
5. Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy;
6. Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) < 50%;
7. Clinically significant valvular heart disease, including aortic valvular disease (moderate or severe aortic stenosis or regurgitation) and/or mitral valve disease (moderate or severe mitral stenosis or regurgitation), or status post mitral valve replacement;
8. Use within 30 days of screening or current use of approved pulmonary hypertension medications such as sildenafil, bosentan or prostacyclines;
9. Use of investigational drugs or devices within 30 days prior to enrollment into the study;
10. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High concentration group	Nitric Oxide Generation and Delivery System	iNO 40ppm，≥2 hours/day for 7 days
Low concentration group	Nitric Oxide Generation and Delivery System	inhaled nitric oxide (iNO) 10ppm，≥2 hours/day for 7 days

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary Exercise Test: Borg score	Baseline, Day 7	Change in Borg score from Baseline after treatment with iNO
Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output（VE/VCO2）	Baseline, Day 7	Change in VE/VCO2 from Baseline after treatment with iNO
Cardiopulmonary Exercise Test: Maximal oxygen uptake（VO2max）	Baseline, Day 7	Change in VO2max from Baseline after treatment with iNO
Cardiopulmonary Exercise Test: oxygen uptake/work (△VO2/△W) ratio	Baseline, Day 7	Change in △VO2/△W ratio from Baseline after treatment with iNO

Secondary Outcome Measures

Name	Time	Method
Adverse events	Baseline up to Day 7	Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100%
Life quality and symptom severity questionnaires: COPD assessment test (CAT)	Baseline, Day 7	Change in CAT scores (0-40 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO
Pulmonary function：FEV1/FVC	Baseline, Day 7	Change in FEV1/FVC from Baseline after treatment with iNO
Life quality and symptom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale	Baseline, Day 7	Change in (mMRC) Dyspnea Scale scores (0-4 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO
Pulmonary function:Forced expiratory volume in 1 second（FEV1）	Baseline, Day 7	Change in FEV1 from Baseline after treatment with iNO
Pulmonary function: Forced vital capacity （FVC）	Baseline, Day 7	Change in FVC from Baseline after treatment with iNO
Six-minute walk test	Baseline, Day 7	Change in exercise capacity from Baseline after treatment with iNO: the distance of six-minute walk test

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China