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Healthy volunteers breathe high-dose nitric oxide to test safety limits

NCT ID NCT05612074

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial at Massachusetts General Hospital is studying how the body processes high doses of inhaled nitric oxide in 10 healthy adults aged 18–64. Participants breathe the gas for 30 minutes, three times a day, while researchers measure methemoglobin levels—a byproduct that can affect oxygen delivery. The goal is to understand how quickly methemoglobin forms and clears, which could inform safer use of nitric oxide in future treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inhaled nitric oxide gas
What this could lead to
If successful, this study could help design safer high-dose nitric oxide therapies for conditions like lung or heart disease.
What could go wrong
This is a very small, early-phase safety study in healthy volunteers, not patients. It does not test any treatment benefit, so results may not apply to sick individuals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

10 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 - 64 years-old volunteers. * Body Mass Index (BMI) 18 - 30 kg/m2. * Absence of current systemic and/or respiratory diseases. * Capacity to consent to the study. Exclusion Criteria: * Evidence of any physical, mental, and/or medical conditions that would make the proposed studies relatively more hazardous. * Systemic and/or respiratory disease with or without any functional limitation. * Left ventricle ejection fraction \< 30%. * Baseline MetHb ≥ 3% * Other conditions of increased risk for MetHb formation: genetic diseases (e.g., glucose-6-phosphate dehydrogenase deficiency, cytochrome b5 reductase deficiency, sickle cell disease), significant anemia or baseline elevation in MetHb. * History of transient ischemic attack or stroke. * Active smoking and tobacco chewers. Volunteers may be enrolled if they quit smoking for more than 1 year and less than 10 pack years total. * Any vaping/e-cigarettes use * Excess alcohol use: more than ½ L/day of wine consumption or equivalent * Current use of any recreational drugs (including the use of medical marijuana) or use of recreational drugs over the past year. * Pregnancy determined by blood pregnancy test detecting presence of human chorionic gonadotropin (hCG). * Less than six weeks postpartum. * Any current medication uses except oral contraceptives. * Lower respiratory infection within the last 30 days. * Claustrophobia (inability to wear a facemask) or other active psychiatric conditions or unwillingness to cooperate with the investigators and other medical teams. * Currently enrolled in another research study. * Facial abnormalities that would preclude proper use of a face mask.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy subjects

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

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