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

Chronic Obstructive Pulmonary Disease Clinical Trial

— NOVEL  

Official title:

Efficacy and Safety of Inhaled Nitric Oxide in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease: a Prospective, Single-center Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896800
• Other study ID #: 2023-COPD-002
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Linfu Zhou, Doctor
• Phone: +8613611573618
• Email: linfu.zhou[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Nitric Oxide Generation and Delivery System
The Nitric Oxide Generation and Delivery System is used to deliver nitric oxide for inhalation therapy into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath.

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Novlead Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary Exercise Test: Maximal oxygen uptake(VO2max)	Change in VO2max from Baseline after treatment with iNO	Baseline, Day 7
Primary	Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output(VE/VCO2)	Change in VE/VCO2 from Baseline after treatment with iNO	Baseline, Day 7
Primary	Cardiopulmonary Exercise Test: Borg score	Change in Borg score from Baseline after treatment with iNO	Baseline, Day 7
Primary	Cardiopulmonary Exercise Test: oxygen uptake/work (?VO2/?W) ratio	Change in ?VO2/?W ratio from Baseline after treatment with iNO	Baseline, Day 7
Secondary	Pulmonary function:Forced expiratory volume in 1 second(FEV1)	Change in FEV1 from Baseline after treatment with iNO	Baseline, Day 7
Secondary	Pulmonary function: Forced vital capacity (FVC)	Change in FVC from Baseline after treatment with iNO	Baseline, Day 7
Secondary	Pulmonary function:FEV1/FVC	Change in FEV1/FVC from Baseline after treatment with iNO	Baseline, Day 7
Secondary	Life quality and symptom severity questionnaires: COPD assessment test (CAT)	Change in CAT scores (0-40 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO	Baseline, Day 7
Secondary	Life quality and symptom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale	Change in (mMRC) Dyspnea Scale scores (0-4 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO	Baseline, Day 7
Secondary	Six-minute walk test	Change in exercise capacity from Baseline after treatment with iNO: the distance of six-minute walk test	Baseline, Day 7
Secondary	Adverse events	Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100%	Baseline up to Day 7