Clinical trial NCT05896800: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Novlead Inc.
First posted: 2023-06-09
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 40 years, ≤ 75 years;
2. Previous smoking history ≥ 10 pack-years, and had stopped smoking for one month before study entry;
3. Met the diagnosis criteria of moderate and severe COPD: a post-bronchodilator FEV1/FVC \< 0.7, and 30%\< FEV1 \< 80% predicted;
4. Signed informed consent and performed all the study mandated procedures.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Current or recent month user of nicotine-like substances (including nicotine patches, etc.);
3. A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator;
4. Lack of patency of nares upon physical examination;
5. Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy;
6. Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) \< 50%;
7. 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;
8. Use within 30 days of screening or current use of approved pulmonary hypertension medications such as sildenafil, bosentan or prostacyclines;
9. Use of investigational drugs or devices within 30 days prior to enrollment into the study;
10. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study.

Primary outcomes:
measure: Cardiopulmonary Exercise Test: Maximal oxygen uptake（VO2max）
timeFrame: Baseline, Day 7
measure: Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output（VE/VCO2）
timeFrame: Baseline, Day 7
measure: Cardiopulmonary Exercise Test: Borg score
timeFrame: Baseline, Day 7
measure: Cardiopulmonary Exercise Test: oxygen uptake/work (△VO2/△W) ratio
timeFrame: Baseline, Day 7
Secondary outcomes:
measure: Pulmonary function:Forced expiratory volume in 1 second（FEV1）
timeFrame: Baseline, Day 7
measure: Pulmonary function: Forced vital capacity （FVC）
timeFrame: Baseline, Day 7
measure: Pulmonary function：FEV1/FVC
timeFrame: Baseline, Day 7
measure: Life quality and symptom severity questionnaires: COPD assessment test (CAT)
timeFrame: Baseline, Day 7
measure: Life quality and symptom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: Baseline, Day 7
measure: Six-minute walk test
timeFrame: Baseline, Day 7
measure: Adverse events
timeFrame: Baseline up to Day 7
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References: