Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05785195
Other study ID # 2022-HX-110
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 14, 2023
Est. completion date March 31, 2024

Study information

Verified date May 2023
Source China-Japan Friendship Hospital
Contact Ruoxi He
Phone +8618874167666
Email heruoxi1985@yeah.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date March 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: 1. Age = 40 years, = 75 years 2. Currently smoking or former smokers with at least 10 pack-years of tobacco cigarette smoking history 3. 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 4. Echocardiogram with technical adequacy demonstrating with Pulmonary Hypertension: Tricuspid regurgitation velocity (TRV) > 2.8 m/s or pulmonary arterial systolic pressure (sPAP) =38mmHg 5. Signed informed consent prior to the initiation of any study mandated procedures or assessments Exclusion Criteria: 1. Experienced an exacerbation requiring start of or increase in systemic oral corticosteroid therapy during the last month 2. Treatment with antibiotics 3. Respiratory failure requiring supplemental oxygen therapy 4. A diagnosis of Interstitial lung disease, asthma, tuberculosis, bronchiectasis, pneumonia, lung cancer, pulmonary embolism, or other non-COPD respiratory disease 5. Any history of lung resection 6. Left ventricular dysfunction: left ventricular ejection fraction (LVEF) < 40% 7. 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 8. Use within 30 days of screening or current use of approved PH medications such as sildenafil, bosentan or prostacyclines 9. Neuromuscular disease or musculoskeletal injuries that unable to complete exercise trials 10. Use of investigational drugs or devices within 30 days prior to enrollment into the study 11. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study

Study Design


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 China-Japan Friendship Hospital Beijing

Sponsors (2)

Lead Sponsor Collaborator
Ting YANG Novlead Inc.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ventilation-perfusion ratio Change in ventilation-perfusion ratio (V/Q) from Baseline after treatment with iNO, measured by pulmonary ventilation/perfusion imaging Baseline, Minutes 30
Primary Tricuspid regurgitation velocity (TRV) Change in TRV from Baseline after treatment with iNO, measured by echocardiogram Baseline, Day 3
Primary Pulmonary arterial systolic pressure (sPAP) Change in sPAP from Baseline after treatment with iNO, measured by echocardiogram Baseline, Day 3
Secondary Percutaneous arterial oxygen saturation (SpO2) Change in SpO2 from Baseline after treatment with iNO Baseline, Day 3
Secondary Pulmonary function:Forced expiratory volume in 1 second(FEV1) Change in FEV1 from Baseline after treatment with iNO Baseline, Day 3
Secondary Pulmonary function: Forced vital capacity (FVC) Change in FVC from Baseline after treatment with iNO Baseline, Day 3
Secondary Pulmonary function: FEV1/FVC Change in ratio of FEV1 and FVC (FEV1/FVC) from Baseline after treatment with iNO Baseline, Day 3
Secondary Pulmonary function: Diffusion lung capacity for carbon monoxide(DLCO) Change in DLCO from Baseline after treatment with iNO Baseline, Day 3
Secondary Cardiopulmonary Exercise Test: Maximal oxygen uptake(VO2max) Change in VO2max from Baseline after treatment with iNO Baseline, Day 3
Secondary Cardiopulmonary Exercise Test: Anaerobic threshold(AT) Change in AT from Baseline after treatment with iNO Baseline, Day 3
Secondary Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output(VE/VCO2) Change in VE/VCO2 from Baseline after treatment with iNO Baseline, Day 3
Secondary Cardiopulmonary Exercise Test: Physiological dead space ventilation (physiological deadspace volume/tidal volume, Vd/Vt) Change in Vd/Vt from Baseline after treatment with iNO Baseline, Day 3
Secondary Six-minute walk distance (6MWD) Change in 6MWD from Baseline after treatment with iNO Baseline, Day 3
Secondary Arterial blood gas: Arterial partial pressure of oxygen (PaO2) Change in PaO2 from Baseline after treatment with iNO Baseline, Day 3
Secondary Arterial blood gas: Arterial partial pressure of carbon dioxide (PaCO2) Change in PaCO2 from Baseline after treatment with iNO Baseline, Day 3
Secondary Arterial blood gas: Alveolar-arterial oxygen partial pressure difference (A-aDO2) Change in A-aDO2 from Baseline after treatment with iNO Baseline, Day 3
Secondary 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 Baseline, Day 3
Secondary 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 Baseline, Day 3
Secondary 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 Baseline, Day 3
Secondary Adverse events Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100% Baseline up to Day 3
See also
  Status Clinical Trial Phase
Completed NCT05102305 - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed NCT01867762 - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Phase 2
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT05552833 - Pulmonary Adaptive Responses to HIIT in COPD N/A
Recruiting NCT05835492 - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Completed NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Withdrawn NCT04446637 - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD Phase 3
Completed NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Withdrawn NCT04042168 - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy