Chronic Obstructive Pulmonary DiseaseNCT05785195
A Mechanistic Study of Inhaled Nitric Oxide in COPD
A study testing Nitric Oxide Generation and Delivery System in people with Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, run by Ting YANG at 1 site in China.
Trial summary
There is a lack of effective treatments for chronic obstructive pulmonary disease (COPD) complicated with pulmonary hypertension. Previous studies have found that inhaled nitric oxide (iNO) can reduce pulmonary artery pressure and improve exercise capacity in COPD with pulmonary hypertension patients. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension
- 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
- 15 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Currently smoking or former smokers with at least 10 pack-years of tobacco cigarette smoking history
- Diagnosis of moderate and severe COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) 2022 criteria: A post-bronchodilatory forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7, and 30%< FEV1 < 80% predicted
- Echocardiogram with technical adequacy demonstrating with Pulmonary Hypertension: Tricuspid regurgitation velocity (TRV) > 2.8 m/s or pulmonary arterial systolic pressure (sPAP) ≥38mmHg
- Signed informed consent prior to the initiation of any study mandated procedures or assessments
Who cannot join
- Experienced an exacerbation requiring start of or increase in systemic oral corticosteroid therapy during the last month
- Treatment with antibiotics
- Respiratory failure requiring supplemental oxygen therapy
- A diagnosis of Interstitial lung disease, asthma, tuberculosis, bronchiectasis, pneumonia, lung cancer, pulmonary embolism, or other non-COPD respiratory disease
- Any history of lung resection
- Left ventricular dysfunction: left ventricular ejection fraction (LVEF) < 40%
Show all 11Show fewer
- Clinically significant valvular heart disease, including aortic valvular disease (moderate or greater aortic stenosis or regurgitation) and/or mitral valve disease (moderate or greater mitral stenosis or regurgitation), or status post mitral valve replacement
- Use within 30 days of screening or current use of approved PH medications such as sildenafil, bosentan or prostacyclines
- Neuromuscular disease or musculoskeletal injuries that unable to complete exercise trials
- 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.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing
Ke HUANG, M.D., 010-84206408
About this study
Official title: Study on the Mechanism of Inhaled Nitric Oxide in the Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) Complicated With Pulmonary Hypertension
There is a lack of effective treatments for chronic obstructive pulmonary disease (COPD) complicated with pulmonary hypertension. Previous studies have found that inhaled nitric oxide (iNO) can reduce pulmonary artery pressure and improve exercise capacity in COPD with pulmonary hypertension patients. However, the specific mechanism is unclear. The study aims to evaluate pulmonary ventilation/perfusion, pulmonary artery pressure, oxygenation, symptoms and quality of life in COPD with pulmonary hypertension patients after short-term treatment with iNO. Observing a series of pathophysiological changes caused by the treatment of pulmonary hypertension with iNO in COPD, the investigators hope to provide new theoretical basis and research ideas.
- Being tested
- Nitric Oxide Generation and Delivery System
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Nitric Oxide (iNO) | Experimental | iNO 20ppm，≥8 hours/day for 3 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.
Ventilation-perfusion ratio
Change in ventilation-perfusion ratio (V/Q) from Baseline after treatment with iNO, measured by pulmonary ventilation/perfusion imaging
Measured: Baseline, Minutes 30
Tricuspid regurgitation velocity (TRV)
Change in TRV from Baseline after treatment with iNO, measured by echocardiogram
Measured: Baseline, Day 3
Pulmonary arterial systolic pressure (sPAP)
Change in sPAP from Baseline after treatment with iNO, measured by echocardiogram
Measured: Baseline, Day 3
Secondary outcomes (17)
Percutaneous arterial oxygen saturation (SpO2)
Change in SpO2 from Baseline after treatment with iNO
Measured: Baseline, Day 3
Pulmonary function:Forced expiratory volume in 1 second（FEV1）
Change in FEV1 from Baseline after treatment with iNO
Measured: Baseline, Day 3
Pulmonary function: Forced vital capacity （FVC）
Change in FVC from Baseline after treatment with iNO
Measured: Baseline, Day 3
Pulmonary function: FEV1/FVC
Change in ratio of FEV1 and FVC (FEV1/FVC) from Baseline after treatment with iNO
Measured: Baseline, Day 3
Pulmonary function: Diffusion lung capacity for carbon monoxide（DLCO)
Change in DLCO from Baseline after treatment with iNO
Measured: Baseline, Day 3
Cardiopulmonary Exercise Test: Maximal oxygen uptake（VO2max）
Change in VO2max from Baseline after treatment with iNO
Measured: Baseline, Day 3
Cardiopulmonary Exercise Test: Anaerobic threshold（AT）
Change in AT from Baseline after treatment with iNO
Measured: Baseline, Day 3
Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output（VE/VCO2）
Change in VE/VCO2 from Baseline after treatment with iNO
Measured: Baseline, Day 3
Cardiopulmonary Exercise Test: Physiological dead space ventilation (physiological deadspace volume/tidal volume, Vd/Vt)
Change in Vd/Vt from Baseline after treatment with iNO
Measured: Baseline, Day 3
Six-minute walk distance (6MWD)
Change in 6MWD from Baseline after treatment with iNO
Measured: Baseline, Day 3
Arterial blood gas: Arterial partial pressure of oxygen (PaO2)
Change in PaO2 from Baseline after treatment with iNO
Measured: Baseline, Day 3
Arterial blood gas: Arterial partial pressure of carbon dioxide (PaCO2)
Change in PaCO2 from Baseline after treatment with iNO
Measured: Baseline, Day 3
Arterial blood gas: Alveolar-arterial oxygen partial pressure difference (A-aDO2)
Change in A-aDO2 from Baseline after treatment with iNO
Measured: Baseline, Day 3
Life quality and symtom 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 3
Life quality and symtom 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 3
Life quality and symtom severity questionnaires: Saint George Respiratory Questionnaire (SGRQ)
Change in SGRQ scores (0-100 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO
Measured: Baseline, Day 3
Adverse events
Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100%
Measured: Baseline up to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start14 Mar 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ting YANG
- Sponsor type
- University, hospital or other
- Collaborators
- Novlead Inc.
- Responsible party
- Sponsor-investigator, Ting YANG, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785195
- Sponsor's protocol ID
- 2022-HX-110
- Status last verified
- May 2023
- First submitted
- 17 Feb 2023
- Last updated
- 15 May 2023
- Results posted
- 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 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mechanism of Inhaled Nitric Oxide in the Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) Complicated With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT05785195
- Acronym / sponsor ID
- 2022-HX-110
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ting YANGUniversity, hospital or other
- Collaborators
- Novlead Inc.
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 27 Mar 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.
There is a lack of effective treatments for chronic obstructive pulmonary disease (COPD) complicated with pulmonary hypertension. Previous studies have found that inhaled nitric oxide (iNO) can reduce pulmonary artery pressure and improve exercise capacity in COPD with pulmonary hypertension patients. However, the specific mechanism is unclear. The study aims to evaluate pulmonary ventilation/perfusion, pulmonary artery pressure, oxygenation, symptoms and quality of life in COPD with pulmonary hypertension patients after short-term treatment with iNO. Observing a series of pathophysiological changes caused by the treatment of pulmonary hypertension with iNO in COPD, the investigators hope to provide new theoretical basis and research ideas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhaled Nitric Oxide (iNO) | Experimental | Device: Nitric Oxide Generation and Delivery SystemiNO 20ppm，≥8 hours/day for 3 days |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 40 years, ≤ 75 years
- Currently smoking or former smokers with at least 10 pack-years of tobacco cigarette smoking history
- Diagnosis of moderate and severe COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) 2022 criteria: A post-bronchodilatory forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7, and 30%< FEV1 < 80% predicted
- Echocardiogram with technical adequacy demonstrating with Pulmonary Hypertension: Tricuspid regurgitation velocity (TRV) > 2.8 m/s or pulmonary arterial systolic pressure (sPAP) ≥38mmHg
- Signed informed consent prior to the initiation of any study mandated procedures or assessments
Key exclusion criteria (11 listed)
- Experienced an exacerbation requiring start of or increase in systemic oral corticosteroid therapy during the last month
- Treatment with antibiotics
- Respiratory failure requiring supplemental oxygen therapy
- A diagnosis of Interstitial lung disease, asthma, tuberculosis, bronchiectasis, pneumonia, lung cancer, pulmonary embolism, or other non-COPD respiratory disease
- Any history of lung resection
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 SystemThe 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. | Device | Inhaled Nitric Oxide (iNO) |
Primary outcome
Ventilation-perfusion ratio
Time frame: Baseline, Minutes 30
Change in ventilation-perfusion ratio (V/Q) from Baseline after treatment with iNO, measured by pulmonary ventilation/perfusion imaging
Tricuspid regurgitation velocity (TRV)
Time frame: Baseline, Day 3
Change in TRV from Baseline after treatment with iNO, measured by echocardiogram
Pulmonary arterial systolic pressure (sPAP)
Time frame: Baseline, Day 3
Change in sPAP from Baseline after treatment with iNO, measured by echocardiogram
17 secondary outcomes
Percutaneous arterial oxygen saturation (SpO2)
Time frame: Baseline, Day 3
Pulmonary function:Forced expiratory volume in 1 second（FEV1）
Time frame: Baseline, Day 3
Pulmonary function: Forced vital capacity （FVC）
Time frame: Baseline, Day 3
Pulmonary function: FEV1/FVC
Time frame: Baseline, Day 3
Pulmonary function: Diffusion lung capacity for carbon monoxide（DLCO)
Time frame: Baseline, Day 3
Cardiopulmonary Exercise Test: Maximal oxygen uptake（VO2max）
Time frame: Baseline, Day 3
Cardiopulmonary Exercise Test: Anaerobic threshold（AT）
Time frame: Baseline, Day 3
Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output（VE/VCO2）
Time frame: Baseline, Day 3
Cardiopulmonary Exercise Test: Physiological dead space ventilation (physiological deadspace volume/tidal volume, Vd/Vt)
Time frame: Baseline, Day 3
Six-minute walk distance (6MWD)
Time frame: Baseline, Day 3
Arterial blood gas: Arterial partial pressure of oxygen (PaO2)
Time frame: Baseline, Day 3
Arterial blood gas: Arterial partial pressure of carbon dioxide (PaCO2)
Time frame: Baseline, Day 3
Arterial blood gas: Alveolar-arterial oxygen partial pressure difference (A-aDO2)
Time frame: Baseline, Day 3
Life quality and symtom severity questionnaires: COPD assessment test (CAT)
Time frame: Baseline, Day 3
Life quality and symtom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: Baseline, Day 3
Life quality and symtom severity questionnaires: Saint George Respiratory Questionnaire (SGRQ)
Time frame: Baseline, Day 3
Adverse events
Time frame: Baseline up to Day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- 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. This study is not recruiting at the moment.
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 and Pulmonary Hypertension, run by Ting YANG 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 15 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruoxi He (+8618874167666, heruoxi1985@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation-perfusion ratio (time frame: Baseline, Minutes 30). The study lists 3 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 15 May 2023.