Inhaled Nitric Oxide for Pneumonia
(iNO300 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether inhaled nitric oxide (iNO) can aid recovery in people severely ill with pneumonia. It examines how the treatment affects methemoglobin levels, a blood component influencing oxygen flow. Participants will receive either the iNO300 Therapy (inhaled nitric oxide treatment) or a placebo that mimics the treatment without the active drug. Those intubated within 72 hours of a pneumonia diagnosis might be suitable candidates. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this potentially groundbreaking therapy.
Is there any evidence suggesting that inhaled nitric oxide therapy is likely to be safe for humans?
Research has shown that inhaled nitric oxide (iNO) therapy is generally safe for humans, even at high doses. Studies have found that using iNO at 300 parts per million (ppm) is well tolerated, with no reported side effects in healthy individuals. This suggests that the treatment is likely safe, even at the higher doses being tested.
In one study, a single dose of iNO at 250 ppm did not cause any significant side effects. Additionally, hospitals have safely used iNO to treat breathing problems like COVID-19. Patients receiving iNO showed improvements without serious side effects. This evidence supports the safety of iNO therapy, making it a promising option for treating pneumonia.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for pneumonia, which typically include antibiotics and supportive care, iNO300 stands out because it uses inhaled nitric oxide to directly target lung inflammation and improve oxygenation. This innovative approach involves delivering high doses of nitric oxide gas, which has potent vasodilatory effects, meaning it helps widen blood vessels in the lungs. Researchers are excited about iNO300 because it could potentially offer rapid relief from symptoms and improve lung function within days, which is much faster than most conventional treatments.
What evidence suggests that iNO300 Therapy might be an effective treatment for pneumonia?
Studies have shown that inhaled nitric oxide (iNO) can help treat pneumonia. One study demonstrated that a high dose of iNO reduced lung bacteria and improved breathing in pneumonia patients. Another study found that 65% of patients with severe illness responded well to iNO. Research also suggests that iNO can reduce the need for extra oxygen, aiding faster recovery. The gas appears to work by enhancing oxygen movement through the lungs. In this trial, participants in the iNO300 group will receive high-dose inhaled nitric oxide, while the control group will receive a sham intervention. These findings support the potential of iNO as a treatment for pneumonia.12467
Who Is on the Research Team?
Lorenzo Berra, MD
Principal Investigator
Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive high dose inhaled nitric oxide therapy starting at 250 ppm, not exceeding 300 ppm, 40 minutes, every 6 hours, from day 1 to day 5
Follow-up
Participants are monitored for safety and effectiveness after treatment, including methemoglobin levels and clinical outcomes
What Are the Treatments Tested in This Trial?
Interventions
- iNO300 Therapy
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
High dose inhaled nitric oxide starting at 250 ppm (not exceeding 300 ppm) , 40min, 4 times daily, from day 1 to day 5. Nitric oxide is delivered using a gas cylinder containing nitric oxide and nitrogen.
Sham intervention with the nitric oxide gas cylinder replaced by that containing only nitrogen and all other delivery procedures identical to the intervention group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
NCT06950294 | iNO300 Therapy in Critically Ill Patients ...
The goal of this clinical trial is to learn the formation and recovery rate of methemoglobin (MetHb) in severely sick patients with pneumonia who receive ...
Inhaled nitric oxide at 300 ppm treats multidrug-resistant ...
aeruginosa pneumonia, intermittent iNO300 therapy resulted in a two-log reduction in bacterial burden, improved oxygenation and lung ...
3.
massgeneralbrigham.org
massgeneralbrigham.org/en/about/newsroom/press-releases/high-dose-ino-potential-antimicrobial-therapy-studyEarly Translational Study Supports the Role of High-Dose ...
“Inhaled nitric oxide at 300 ppm treats multidrug-resistant Pseudomonas pneumonia in swine and is safe in humans” Science Translational ...
4.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT06950294/ino300-therapy-in-critically-ill-patients-with-pneumoniaiNO300 Therapy in Critically Ill Patients With Pneumonia
Receive iNO treatment starting at 250 ppm, not exceeding 300 ppm, 40 min, every 6 hours, from day 1 to day 5. Be followed up for 60 days.
Efficacy and safety of inhaled nitric oxide in the treatment of ...
They found a response rate of 65% after the treatment of iNO without practicing prone positioning. Feng et al., 2020[13] reported that iNO was significantly ...
The therapeutic potential of high-dose inhaled nitric oxide for ...
This review summarizes translational and early clinical data and outlines a roadmap for future trials needed to define safety, efficacy, and ...
A safety evaluation of intermittent high-dose inhaled nitric ...
Consistent with our results, these found that high-dose iNO treatment (160-ppm) was safe, reduced tachypnoea, and improved oxygenation of ...
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