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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nitric Oxide Generation and Delivery System
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Pregnant or lactating women; Current or recent month user of nicotine-like substances (including nicotine patches, etc.); A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator; Lack of patency of nares upon physical examination; Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy; Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) < 50%; 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; Use within 30 days of screening or current use of approved pulmonary hypertension medications such as sildenafil, bosentan or prostacyclines; Use of investigational drugs or devices within 30 days prior to enrollment into the study; Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study.

Sites / Locations

  • The First Affiliated Hospital with Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low concentration group

High concentration group

Arm Description

inhaled nitric oxide (iNO) 10ppm,≥2 hours/day for 7 days

iNO 40ppm,≥2 hours/day for 7 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pulmonary function:Forced expiratory volume in 1 second(FEV1)
Change in FEV1 from Baseline after treatment with iNO
Pulmonary function: Forced vital capacity (FVC)
Change in FVC from Baseline after treatment with iNO
Pulmonary function:FEV1/FVC
Change in FEV1/FVC from Baseline after treatment with iNO
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
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
Six-minute walk test
Change in exercise capacity from Baseline after treatment with iNO: the distance of six-minute walk test
Adverse events
Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100%

Full Information

First Posted
June 1, 2023
Last Updated
October 7, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Novlead Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05896800
Brief Title
A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Novlead Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low concentration group
Arm Type
Experimental
Arm Description
inhaled nitric oxide (iNO) 10ppm,≥2 hours/day for 7 days
Arm Title
High concentration group
Arm Type
Experimental
Arm Description
iNO 40ppm,≥2 hours/day for 7 days
Intervention Type
Device
Intervention Name(s)
Nitric Oxide Generation and Delivery System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiopulmonary Exercise Test: Maximal oxygen uptake(VO2max)
Description
Change in VO2max from Baseline after treatment with iNO
Time Frame
Baseline, Day 7
Title
Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output(VE/VCO2)
Description
Change in VE/VCO2 from Baseline after treatment with iNO
Time Frame
Baseline, Day 7
Title
Cardiopulmonary Exercise Test: Borg score
Description
Change in Borg score from Baseline after treatment with iNO
Time Frame
Baseline, Day 7
Title
Cardiopulmonary Exercise Test: oxygen uptake/work (△VO2/△W) ratio
Description
Change in △VO2/△W ratio from Baseline after treatment with iNO
Time Frame
Baseline, Day 7
Secondary Outcome Measure Information:
Title
Pulmonary function:Forced expiratory volume in 1 second(FEV1)
Description
Change in FEV1 from Baseline after treatment with iNO
Time Frame
Baseline, Day 7
Title
Pulmonary function: Forced vital capacity (FVC)
Description
Change in FVC from Baseline after treatment with iNO
Time Frame
Baseline, Day 7
Title
Pulmonary function:FEV1/FVC
Description
Change in FEV1/FVC from Baseline after treatment with iNO
Time Frame
Baseline, Day 7
Title
Life quality and symptom severity questionnaires: COPD assessment test (CAT)
Description
Change in CAT scores (0-40 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO
Time Frame
Baseline, Day 7
Title
Life quality and symptom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale
Description
Change in (mMRC) Dyspnea Scale scores (0-4 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO
Time Frame
Baseline, Day 7
Title
Six-minute walk test
Description
Change in exercise capacity from Baseline after treatment with iNO: the distance of six-minute walk test
Time Frame
Baseline, Day 7
Title
Adverse events
Description
Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100%
Time Frame
Baseline up to Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Pregnant or lactating women; Current or recent month user of nicotine-like substances (including nicotine patches, etc.); A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator; Lack of patency of nares upon physical examination; Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy; Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) < 50%; 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; Use within 30 days of screening or current use of approved pulmonary hypertension medications such as sildenafil, bosentan or prostacyclines; Use of investigational drugs or devices within 30 days prior to enrollment into the study; Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linfu Zhou, Doctor
Phone
+8613611573618
Email
linfu.zhou@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liuchao Zhang, Master
Phone
+8615850423930
Facility Information:
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linfu Zhou, Doctor
Phone
+8613611573618
Email
linfu.zhou@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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