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Vasodilator

Inhaled Nitric Oxide for Healthy Subjects

Phase < 1
Recruiting
Led By Lorenzo Berra, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Study Summary

This trial will investigate how nitric oxide affects red blood cells in healthy people. Participants will breathe varying concentrations of nitric oxide and oxygen and be monitored.

Who is the study for?
This trial is for healthy volunteers aged 18-64 with a BMI of 18-30 kg/m^2, no respiratory diseases, and not currently on medication (except oral contraceptives). Smokers or those who use recreational drugs including marijuana are excluded. Pregnant women and individuals with certain genetic diseases or recent infections are also ineligible.Check my eligibility
What is being tested?
The study tests how the body processes methemoglobin when breathing high doses of inhaled nitric oxide up to 300 parts per million. It looks at how quickly methemoglobin forms and reduces after stopping nitric oxide, monitoring participants continuously during exposure.See study design
What are the potential side effects?
Potential side effects may include increased levels of methemoglobin which can reduce oxygen delivery in the blood if it becomes too high. Participants will be closely monitored for any adverse reactions during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Methemoglobin
Secondary outcome measures
Brain Diseases, Metabolic
Nitrogen Dioxide

Side effects data

From 2014 Phase 3 trial • 451 Patients • NCT00931632
29%
Hyponatraemia
15%
Patent ductus arteriosus
13%
Bronchopulmonary dysplasia
13%
Metabolic acidosis
11%
Sepsis
6%
Hyperglycemia
5%
Pulmonary edema
5%
Necrotising enterocolitis neonatal
4%
Feeding disorder neonatal
4%
Atelectasis
3%
Staphylococcal sepsis
3%
Intestinal perforation
3%
Hypotension
2%
Pneumothorax
2%
Anemia neonatal
1%
Abdominal distension
1%
Urinary tract infection
1%
Fungal sepsis
1%
Group B streptococcus neonatal sepsis
1%
Pneumonia bacterial
1%
Intraventricular hemorrhage neonatal
1%
Pneumonia
1%
Hydrocephalus
1%
Infantile apnoeic attack
1%
Thrombocytopenia
1%
Septic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Inhaled Nitric Oxide
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nitric OxideExperimental Treatment1 Intervention
High dose inhaled nitric oxide (targeting 250 ppm and not exceeding 300 ppm) in a nitrogen-oxygen-air mixture, at two different FiO2 levels (0.21 and 0.8) will be delivered intermittently with a dedicated system and a snug-fitting facemask to healthy volunteers three times per day for 5 days. The subjects will be monitored before, during and after the administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inhaled Nitric Oxide
2011
Completed Phase 3
~780

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,631 Total Patients Enrolled
Lorenzo Berra, MDPrincipal InvestigatorMassachusetts General Hospital
16 Previous Clinical Trials
824 Total Patients Enrolled

Media Library

Inhaled Nitric Oxide (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT05612074 — Phase < 1
Healthy Subjects Research Study Groups: Nitric Oxide
Healthy Subjects Clinical Trial 2023: Inhaled Nitric Oxide Highlights & Side Effects. Trial Name: NCT05612074 — Phase < 1
Inhaled Nitric Oxide (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05612074 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open vacancies for this trial's participants?

"Per clinicaltrials.gov, this research is no longer enrolling participants as it has not been updated since November 9th 2022. However, there are a wealth of other trials currently recruiting upon which patients can embark."

Answered by AI

Does the upper age limit for this clinical experiment include those aged 85 and under?

"This research study is only accepting participants between 18 to 64 years of age. However, there are separate trials suited for those under the legal age and seniors over 65 respectively with 50 studies and 370 studies available in total."

Answered by AI

To what demographic is this research project open?

"To qualify for this clinical study, interested patients must be of hale and hearty health and aged 18-64. A maximum of 30 participants can join the trial."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Methemoglobin Concentration in High Dose Inhaled Nitric Oxide
Lorenzo Berra, MD 2023. "Methemoglobin Concentration in High Dose Inhaled Nitric Oxide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05612074.
~7 spots leftby Jun 2025
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