Effect of Inhaled Nitric Oxide Therapy in Adults With Moderate-to-Severe Acute Respiratory Distre… (NCT07334873) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Inhaled Nitric Oxide Therapy in Adults With Moderate-to-Severe Acute Respiratory Distress Syndrome
China536 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years.
* Patients diagnosed with moderate-to-severe ARDS according to the 2023 Global (or international) criteria.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring 28-day mortality as its main outcome — does that mean it's still unknown whether inhaled nitric oxide actually improves survival for moderate-to-severe ARDS, and how does that uncertainty affect whether this might be right for me?
2The trial is listed as 'not yet recruiting' — given how quickly ARDS can progress, is there any realistic chance this study would even be available in time, and are there other active trials or standard treatments I should be considering right now instead?
3Inhaled nitric oxide has to be delivered continuously through a breathing machine — what does that mean practically for how I'd be cared for, and is that level of intervention something that fits my current condition and wishes?
4Since this trial is Phase NA, which sometimes means it's an early or exploratory study, what does that tell us about how much is already known about the safety of inhaled nitric oxide at the doses being tested here?
5Are there standard-of-care treatments for moderate-to-severe ARDS that have more established evidence behind them that I should try first, before considering enrolling in a trial that hasn't even started recruiting yet?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
28-day mortality
Timeframe: within 28 days after randomization
Trial details
NCT IDNCT07334873
SponsorNanfang Hospital, Southern Medical University