Efficacy and safety of high doses of inhaled nitric oxide in patients with community-acquired pneumonia: a pilot study

Abstract

For the first time, the effectiveness and safety of high doses of inhaled nitric oxide (iNO) in patients with community-acquired pneumonia (CAP) has been demonstrated.The aim of the study was to examine the effectiveness and safety of adding iNO to standard treatment for patients with CAP.Methods. A pilot, single-center, prospective, randomized, open-label clinical trial was conducted, which included patients (n = 120) hospitalized with CAP. Randomization was carried out using the blind envelope method. Patients in the main group (n = 60) received iNO through nasal cannulas using the Tianox iNO therapy device (AIT-NO-Ol according to TU 32.50. 21-001-07623615-2017) in addition to the therapy according to the standard of care at the study center. Inhalations were carried out with high doses of NO, namely 200 ppm for 15 minutes 3 times a day, regardless of food intake. Patients in the control group (n = 60) received only the therapy recommended by the standard of care at the study center. Clinical and laboratory parameters were assessed and safety of the therapy was monitored during the study.Results. No significant differences were identified between the main group and the control group in demographic, clinical, laboratory and instrumental data at baseline. Patients receiving iNO as an adjunct to standard therapy had a more significant improvement in clinical symptoms starting from the 3rd day and better oxygenation parameters on the 7th day of therapy. There was a more significant decrease in the level of C-reactive protein on the 5th and 7th days of therapy and a more significant decrease in the level of leukocytes on the 5th day in the main group. The duration of hospitalization in the main group was significantly shorter than that in the control group. NO inhalation was not associated with any side effects and was well tolerated.Conclusion. The use of high doses of NO has a positive effect on the clinical status, markers of inflammation, reduces the length of hospitalization, and demonstrates good tolerability and safety in patients with CAP.