Chronic Obstructive Pulmonary DiseaseNOVELNCT05896800
A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease
A study testing Inhaled nitric oxide (NO) and air in people with Chronic Obstructive Pulmonary Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inhaled nitric oxide (NO) and air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Liuchao Zhang, Master contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
Linfu Zhou, Doctor, +8613611573618, linfu.zhou@126.com
About this study
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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inhaled nitric oxide (NO), air
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled nitric oxide (NO)Other
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.
airOther
use air（21%O2）as the placebo of inhaled treatment
| Study group | Role | What they receive |
|---|---|---|
| Low concentration group | Experimental | inhaled nitric oxide (iNO) 10ppm，≥2 hours/day for 7 days Receives: Other: Inhaled nitric oxide (NO) |
| High concentration group | Experimental | iNO 40ppm，≥2 hours/day for 7 days Receives: Other: Inhaled nitric oxide (NO) |
| Placebo group | Placebo comparator | patient inhaled placebo treatment Receives: Other: air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary Exercise Test: Maximal oxygen uptake（VO2max）
Change in VO2max from Baseline after treatment with iNO
Measured: Baseline, Day 7
Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output（VE/VCO2）
Change in VE/VCO2 from Baseline after treatment with iNO
Measured: Baseline, Day 7
Cardiopulmonary Exercise Test: Borg score
Change in Borg score from Baseline after treatment with iNO
Measured: Baseline, Day 7
Cardiopulmonary Exercise Test: oxygen uptake/work (△VO2/△W) ratio
Change in △VO2/△W ratio from Baseline after treatment with iNO
Measured: Baseline, Day 7
Secondary outcomes (7)
Pulmonary function:Forced expiratory volume in 1 second（FEV1）
Change in FEV1 from Baseline after treatment with iNO
Measured: Baseline, Day 7
Pulmonary function: Forced vital capacity （FVC）
Change in FVC from Baseline after treatment with iNO
Measured: Baseline, Day 7
Pulmonary function：FEV1/FVC
Change in FEV1/FVC from Baseline after treatment with iNO
Measured: Baseline, Day 7
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
Measured: Baseline, Day 7
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
Measured: Baseline, Day 7
Six-minute walk test
Change in exercise capacity from Baseline after treatment with iNO: the distance of six-minute walk test
Measured: Baseline, Day 7
Adverse events
Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100%
Measured: Baseline up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Novlead Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896800
- Sponsor's protocol ID
- 2023-COPD-002
- Acronym
- NOVEL
- Status last verified
- May 2025
- First submitted
- 1 Jun 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05896800
- Acronym / sponsor ID
- NOVEL / 2023-COPD-002
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Novlead Inc.
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low concentration group | Experimental | Other: Inhaled nitric oxide (NO)inhaled nitric oxide (iNO) 10ppm，≥2 hours/day for 7 days |
| High concentration group | Experimental | Other: Inhaled nitric oxide (NO)iNO 40ppm，≥2 hours/day for 7 days |
| Placebo group | Placebo comparator | Other: airpatient inhaled placebo treatment |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled nitric oxide (NO)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. | Other | High concentration group, Low concentration group |
| airuse air（21%O2）as the placebo of inhaled treatment | Other | Placebo group |
Primary outcome
Cardiopulmonary Exercise Test: Maximal oxygen uptake（VO2max）
Time frame: Baseline, Day 7
Change in VO2max from Baseline after treatment with iNO
Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output（VE/VCO2）
Time frame: Baseline, Day 7
Change in VE/VCO2 from Baseline after treatment with iNO
Cardiopulmonary Exercise Test: Borg score
Time frame: Baseline, Day 7
Change in Borg score from Baseline after treatment with iNO
Cardiopulmonary Exercise Test: oxygen uptake/work (△VO2/△W) ratio
Time frame: Baseline, Day 7
Change in △VO2/△W ratio from Baseline after treatment with iNO
7 secondary outcomes
Pulmonary function:Forced expiratory volume in 1 second（FEV1）
Time frame: Baseline, Day 7
Pulmonary function: Forced vital capacity （FVC）
Time frame: Baseline, Day 7
Pulmonary function：FEV1/FVC
Time frame: Baseline, Day 7
Life quality and symptom severity questionnaires: COPD assessment test (CAT)
Time frame: Baseline, Day 7
Life quality and symptom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: Baseline, Day 7
Six-minute walk test
Time frame: Baseline, Day 7
Adverse events
Time frame: Baseline up to Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liuchao Zhang, Master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled nitric oxide (NO) and air in people with Chronic Obstructive Pulmonary Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linfu Zhou, Doctor (+8613611573618, linfu.zhou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary Exercise Test: Maximal oxygen uptake（VO2max） (time frame: Baseline, Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.