Menu
Recruiting NCT07382258

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

No phase Interventional Chronic Obstructive Pulmonary Disease (COPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nitric Oxide Generation and Delivery System.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Single-Center Study of Inhaled Nitric Oxide in Individuals Diagnosed With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

Overview

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.

Interventions

  • Device Nitric Oxide Generation and Delivery System
    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.

Primary outcome measures

  • Change in Maximal Oxygen Uptake (VO2max) [Time frame: Baseline, Day 7]
  • Change in Ventilatory Efficiency (VE/VCO2) [Time frame: Baseline, Day 7]
  • Change in Oxygen Uptake to Work Rate Ratio (ΔVO2/ΔW) [Time frame: Baseline, Day 7]
  • Change in Perceived Exertion (Borg Score) [Time frame: Baseline, Day 7]
Secondary outcome measures (6)
  • Change in COPD Assessment Test (CAT) Score [Time frame: Baseline, Day 7]
  • Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score [Time frame: Baseline, Day 7]
  • Change in Six-Minute Walk Distance (6MWD) [Time frame: Baseline, Day 7]
  • Change in Forced Expiratory Volume in 1 Second (FEV1) [Time frame: Baseline, Day 7]
  • Change in Forced Vital Capacity (FVC) [Time frame: Baseline, Day 7]
  • Change in FEV1/FVC Ratio [Time frame: Baseline, Day 7]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Experienced a COPD exacerbation within the past month requiring initiation or escalation of systemic corticosteroids.
  • Impaired left ventricular systolic function, defined as left ventricular ejection fraction (LVEF) < 50%.
  • Significant valvular heart disease (moderate/severe aortic or mitral stenosis/regurgitation) or prior mitral valve replacement.
  • Use of approved pulmonary hypertension medications (e.g., sildenafil, bosentan, prostacyclins) within 30 days prior to screening or during the study.
  • Participation in another interventional clinical trial involving drugs or devices within 30 days prior to enrollment.
  • Any other medical or psychiatric condition that, in the investigator's judgment, would compromise patient safety or study integrity.

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: NCT07382258 · INO-COPD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗