Effect of Inhaled Nitric Oxide Therapy in Adults With Moderate-to-Severe Acute Respiratory Distress Syndrome

NCT07334873 | Not Yet Recruiting

• 1 other identifier: NFEC-2025-708
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether inhaled nitric oxide (iNO), added to standard care, can reduce mortality in adults with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). The main questions it aims to answer are: Does iNO therapy reduce 28-day all-cause mortality compared to standard care alone? Does iNO therapy increase the number of ventilator-free days through day 28? If there is a comparison group: Researchers will compare the group receiving iNO plus standard care with the group receiving placebo plus standard care to see if iNO improves survival and other clinical outcomes. Participants will: Be randomly assigned to receive either iNO or a placebo through the ventilator. Receive all other standard treatments for ARDS as per current guidelines. Be closely monitored for 28 days to track survival, time on the ventilator, and safety.

Conditions

ARDS (Moderate or Severe)

Keywords

Inhaled Nitric Oxide Therapy; ARDS

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  The primary outcome was 28-day all-cause mortality, defined as death from any cause occurring within 28 days following randomization. All patients must be followed up through day 28, regardless of hospital discharge status.

  within 28 days after randomization

Study Arms (1)

Standard of care for ARDS+Inhaled Nitric Oxide

EXPERIMENTAL

Procedure: Inhaled Nitric Oxide Therapy

Interventions

Inhaled Nitric Oxide Therapy PROCEDURE

Patients randomized to the intervention group will receive inhaled nitric oxide (iNO) delivered via the portable INOwill N200 system in addition to standard ARDS care. iNO administration will commence immediately upon enrollment, with its concentration set and titrated in accordance with established clinical practice guidelines.

Standard of care for ARDS+Inhaled Nitric Oxide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Patients diagnosed with moderate-to-severe ARDS according to the 2023 Global (or international) criteria.

You may not qualify if:

• Known allergy to iNO.
• Congenital methemoglobinemia.
• End-stage chronic lung disease (e.g., lung cancer, prior pneumonectomy/lung transplant).
• Shock (norepinephrine \>0.5 μg/kg/min or equivalent for \>6 hours) at treatment initiation.
• Pulmonary hypertension (PASP \>45 mmHg by echo or mPAP ≥25 mmHg by catheterization).
• Serum creatinine \>2.5 mg/dL (221 μmol/L).
• Major bleeding (e.g., intracranial, pulmonary) or platelet count \<20×10⁹/L.
• Expected ICU/mechanical ventilation \<24 hours.
• Pre-enrollment ECMO therapy.
• Any investigator-assessed unsuitability for the study.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

CN (1)