A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

ConditionChronic Obstructive Pulmonary Disease (COPD)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-75

SponsorNovlead Inc.

About this trial

This clinical trial aims to assess the impact on exercise tolerance and the safety of inhaled nitric oxide in subjects with moderate-to-severe COPD. The findings are expected to contribute to the development of safe and effective therapeutic strategies for COPD management.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 40 and 75 years, inclusive.

History of smoking with a cumulative exposure of ≥10 pack-years, and having ceased smoking for at least one month prior to study participation.

Diagnosis of moderate-to-severe COPD confirmed by post-bronchodilator spirometry: FEV1/FVC < 0.7 and FEV1 between 30% and 80% of predicted value.

Willing and able to provide written informed consent and comply with all study-related procedures.

Disqualifiers

Pregnancy or lactation.

Use of nicotine-containing products (e.g., patches, gum) within the past month.

Current diagnosis of asthma or any other active respiratory condition considered non-COPD by the investigator.

Physical obstruction of the nasal passages.

Trial design

Design model

Parallel

Treatments tested in this trial

Nitric Oxide Generation and Delivery System
Device
A device designed to deliver a stable, user-prescribed concentration of nitric oxide gas into the inspiratory circuit of the patient's breathing apparatus for inhalation therapy.

Treatment groups

16 Participants

are divided into 2 treatment groups

Group A: iNO 10 ppm Dose GroupExperimental treatment 1 intervention

Group B: iNO 40 ppm Dose GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in Maximal Oxygen Uptake (VO2max)

The difference in VO2max values measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.

Time frame

Baseline, Day 7

Change in Ventilatory Efficiency (VE/VCO2)

The difference in the minute ventilation-to-carbon dioxide output (VE/VCO2) ratio measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.

Time frame

Baseline, Day 7

Change in Oxygen Uptake to Work Rate Ratio (ΔVO2/ΔW)

The difference in the ratio of change in oxygen uptake to change in work rate (ΔVO2/ΔW) measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.

Time frame

Baseline, Day 7

Change in Perceived Exertion (Borg Score)

The difference in Borg scale scores for perceived exertion recorded during cardiopulmonary exercise testing before and after the one-week iNO treatment period.

Time frame

Baseline, Day 7

Secondary outcomes

Change in COPD Assessment Test (CAT) Score

The difference in total CAT score (range 0-40, higher scores indicate worse health status) reported before and after the one-week iNO treatment period.

Time frame

Baseline, Day 7

Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score

The difference in mMRC dyspnea scale score (range 0-4, higher scores indicate greater breathlessness) reported before and after the one-week iNO treatment period.

Time frame

Baseline, Day 7

Change in Six-Minute Walk Distance (6MWD)

The difference in the distance walked during a six-minute walk test performed before and after the one-week iNO treatment period.

Time frame

Baseline, Day 7

Change in Forced Expiratory Volume in 1 Second (FEV1)

The difference in FEV1 values from pulmonary function tests performed before and after the one-week iNO treatment period.

Time frame

Baseline, Day 7

Other outcomes

Incidence of Treatment-Emergent Adverse Events

Proportion of participants experiencing any adverse event during the treatment period, calculated as (Number of subjects with adverse events / Total number of treated subjects) \* 100%.

Time frame

Baseline up to Day 7

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novlead Inc.

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Source ClinicalTrials.gov

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