Chronic Obstructive Pulmonary Disease (COPD)NCT07382258
A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease
A study testing Nitric Oxide Generation and Delivery System in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novlead Inc. at 1 site in China.
Trial summary
This clinical trial aims to assess the impact on exercise tolerance and the safety of inhaled nitric oxide in subjects with moderate-to-severe COPD. The findings are expected to contribute to the development of safe and effective therapeutic strategies for COPD management. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Nitric Oxide Generation and Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2023to 30 Apr 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
- Aged between 40 and 75 years, inclusive.
- History of smoking with a cumulative exposure of ≥10 pack-years, and having ceased smoking for at least one month prior to study participation.
- Diagnosis of moderate-to-severe COPD confirmed by post-bronchodilator spirometry: FEV1/FVC < 0.7 and FEV1 between 30% and 80% of predicted value.
- Willing and able to provide written informed consent and comply with all study-related procedures.
Who cannot join
- Pregnancy or lactation.
- Use of nicotine-containing products (e.g., patches, gum) within the past month.
- Current diagnosis of asthma or any other active respiratory condition considered non-COPD by the investigator.
- Physical obstruction of the nasal passages.
- Experienced a COPD exacerbation within the past month requiring initiation or escalation of systemic corticosteroids.
- Impaired left ventricular systolic function, defined as left ventricular ejection fraction (LVEF) < 50%.
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- Significant valvular heart disease (moderate/severe aortic or mitral stenosis/regurgitation) or prior mitral valve replacement.
- Use of approved pulmonary hypertension medications (e.g., sildenafil, bosentan, prostacyclins) within 30 days prior to screening or during the study.
- Participation in another interventional clinical trial involving drugs or devices within 30 days prior to enrollment.
- Any other medical or psychiatric condition that, in the investigator's judgment, would compromise patient safety or study integrity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
Ning Ding, Doctor, +8619941515661, dingning@njmu.edu.cn
About this study
Official title: A Prospective, Single-Center Study of Inhaled Nitric Oxide in Individuals Diagnosed With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
This clinical trial aims to assess the impact on exercise tolerance and the safety of inhaled nitric oxide in subjects with moderate-to-severe COPD. The findings are expected to contribute to the development of safe and effective therapeutic strategies for COPD management.
- Being tested
- Nitric Oxide Generation and Delivery System
- Keywords
- COPD
- 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.
Nitric Oxide Generation and Delivery SystemDevice
A device designed to deliver a stable, user-prescribed concentration of nitric oxide gas into the inspiratory circuit of the patient's breathing apparatus for inhalation therapy.
| Study group | Role | What they receive |
|---|---|---|
| iNO 10 ppm Dose Group | Experimental | Participants will receive inhaled nitric oxide at a concentration of 10 ppm, for a minimum of 2 hours per day, over 7 consecutive days. Receives: Device: Nitric Oxide Generation and Delivery System |
| iNO 40 ppm Dose Group | Experimental | Participants will receive inhaled nitric oxide at a concentration of 40 ppm, for a minimum of 2 hours per day, over 7 consecutive days. Receives: Device: Nitric Oxide Generation and Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal Oxygen Uptake (VO2max)
The difference in VO2max values measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
Measured: Baseline, Day 7
Change in Ventilatory Efficiency (VE/VCO2)
The difference in the minute ventilation-to-carbon dioxide output (VE/VCO2) ratio measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
Measured: Baseline, Day 7
Change in Oxygen Uptake to Work Rate Ratio (ΔVO2/ΔW)
The difference in the ratio of change in oxygen uptake to change in work rate (ΔVO2/ΔW) measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
Measured: Baseline, Day 7
Change in Perceived Exertion (Borg Score)
The difference in Borg scale scores for perceived exertion recorded during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
Measured: Baseline, Day 7
Secondary outcomes (6)
Change in COPD Assessment Test (CAT) Score
The difference in total CAT score (range 0-40, higher scores indicate worse health status) reported before and after the one-week iNO treatment period.
Measured: Baseline, Day 7
Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score
The difference in mMRC dyspnea scale score (range 0-4, higher scores indicate greater breathlessness) reported before and after the one-week iNO treatment period.
Measured: Baseline, Day 7
Change in Six-Minute Walk Distance (6MWD)
The difference in the distance walked during a six-minute walk test performed before and after the one-week iNO treatment period.
Measured: Baseline, Day 7
Change in Forced Expiratory Volume in 1 Second (FEV1)
The difference in FEV1 values from pulmonary function tests performed before and after the one-week iNO treatment period.
Measured: Baseline, Day 7
Change in Forced Vital Capacity (FVC)
The difference in FVC values from pulmonary function tests performed before and after the one-week iNO treatment period.
Measured: Baseline, Day 7
Change in FEV1/FVC Ratio
The difference in the FEV1/FVC ratio from pulmonary function tests performed before and after the one-week iNO treatment period.
Measured: Baseline, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start17 May 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 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 Disease (COPD)Studies of the same condition, open and under way.
- 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novlead Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382258
- Sponsor's protocol ID
- INO-COPD
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 2 Feb 2026
- 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center Study of Inhaled Nitric Oxide in Individuals Diagnosed With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07382258
- Acronym / sponsor ID
- INO-COPD
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Novlead Inc.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University
- Study start
- 17 May 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 2 Feb 2026 (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.
This clinical trial aims to assess the impact on exercise tolerance and the safety of inhaled nitric oxide in subjects with moderate-to-severe COPD. The findings are expected to contribute to the development of safe and effective therapeutic strategies for COPD management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iNO 10 ppm Dose Group | Experimental | Device: Nitric Oxide Generation and Delivery SystemParticipants will receive inhaled nitric oxide at a concentration of 10 ppm, for a minimum of 2 hours per day, over 7 consecutive days. |
| iNO 40 ppm Dose Group | Experimental | Device: Nitric Oxide Generation and Delivery SystemParticipants will receive inhaled nitric oxide at a concentration of 40 ppm, for a minimum of 2 hours per day, over 7 consecutive days. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 40 and 75 years, inclusive.
- History of smoking with a cumulative exposure of ≥10 pack-years, and having ceased smoking for at least one month prior to study participation.
- Diagnosis of moderate-to-severe COPD confirmed by post-bronchodilator spirometry: FEV1/FVC < 0.7 and FEV1 between 30% and 80% of predicted value.
- Willing and able to provide written informed consent and comply with all study-related procedures.
Key exclusion criteria (10 listed)
- Pregnancy or lactation.
- Use of nicotine-containing products (e.g., patches, gum) within the past month.
- Current diagnosis of asthma or any other active respiratory condition considered non-COPD by the investigator.
- Physical obstruction of the nasal passages.
- Experienced a COPD exacerbation within the past month requiring initiation or escalation of systemic corticosteroids.
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 |
|---|---|---|
| Nitric Oxide Generation and Delivery SystemA device designed to deliver a stable, user-prescribed concentration of nitric oxide gas into the inspiratory circuit of the patient's breathing apparatus for inhalation therapy. | Device | iNO 10 ppm Dose Group, iNO 40 ppm Dose Group |
Primary outcome
Change in Maximal Oxygen Uptake (VO2max)
Time frame: Baseline, Day 7
The difference in VO2max values measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
Change in Ventilatory Efficiency (VE/VCO2)
Time frame: Baseline, Day 7
The difference in the minute ventilation-to-carbon dioxide output (VE/VCO2) ratio measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
Change in Oxygen Uptake to Work Rate Ratio (ΔVO2/ΔW)
Time frame: Baseline, Day 7
The difference in the ratio of change in oxygen uptake to change in work rate (ΔVO2/ΔW) measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
Change in Perceived Exertion (Borg Score)
Time frame: Baseline, Day 7
The difference in Borg scale scores for perceived exertion recorded during cardiopulmonary exercise testing before and after the one-week iNO treatment period.
6 secondary outcomes
Change in COPD Assessment Test (CAT) Score
Time frame: Baseline, Day 7
Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score
Time frame: Baseline, Day 7
Change in Six-Minute Walk Distance (6MWD)
Time frame: Baseline, Day 7
Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, Day 7
Change in Forced Vital Capacity (FVC)
Time frame: Baseline, Day 7
Change in FEV1/FVC Ratio
Time frame: Baseline, 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 2 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitric Oxide Generation and Delivery System in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novlead Inc. 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 2 Feb 2026. 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. 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 Chenxi Wu, Master (+8615850568410, chenxi.wu@novlead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 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 2 Feb 2026.