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

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

Overview

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.

Interventions

• Other 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 air
  use air（21%O2）as the placebo of inhaled treatment

Primary outcome measures

• Cardiopulmonary Exercise Test: Maximal oxygen uptake（VO2max） [Time frame: Baseline, Day 7]
• Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output（VE/VCO2） [Time frame: Baseline, Day 7]
• Cardiopulmonary Exercise Test: Borg score [Time frame: Baseline, Day 7]
• Cardiopulmonary Exercise Test: oxygen uptake/work (△VO2/△W) ratio [Time frame: Baseline, Day 7]

Secondary outcome measures (7)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital with Nanjing Medical University — Nanjing

Identifiers

NCT: NCT05896800 · 2023-COPD-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗