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

Официальное название

Efficacy and Safety of Inhaled Nitric Oxide in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease: a Prospective, Single-center Clinical Trial

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (7)

• Pulmonary function:Forced expiratory volume in 1 second（FEV1） [Срок оценки: Baseline, Day 7]
• Pulmonary function: Forced vital capacity （FVC） [Срок оценки: Baseline, Day 7]
• Pulmonary function：FEV1/FVC [Срок оценки: Baseline, Day 7]
• Life quality and symptom severity questionnaires: COPD assessment test (CAT) [Срок оценки: Baseline, Day 7]
• Life quality and symptom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale [Срок оценки: Baseline, Day 7]
• Six-minute walk test [Срок оценки: Baseline, Day 7]
• Adverse events [Срок оценки: Baseline up to Day 7]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital with Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT05896800 · 2023-COPD-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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