To estimate the efficacy of inhaled corticosteroid in-patient of moderate COVID-19 pneumonia - randomized controlled study

Background: Systemic corticosteroids have been found to reduce the mortality in patients with moderated and severe COVID-19 pneumonia in the first and second waves of the pandemic but had the unwanted effects which can be avoided when the corticosteroids are given via the inhalational route (ICS). Therefore in this study, we aimed to investigate whether Inhaled Corticosteroid MDI -Budesonide could reduce the morbidity in patients with moderate COVID-19 pneumonia. Our primary objective was to study the time to clinical improvement in days (Time Frame: Up to 14 days)defined as the resolution of all systemic and respiratory symptoms (SPO2 > 92% in room air, RR 14-16/min, for ≥2 consecutive days). Materials and Methods: After obtaining approval from Institute Research and Ethics committee and following CTRI registration, this randomized controlled study was carried out from January to March 2022 in a covid dedicated hospital. Eighty participants were enrolled and written informed consent was obtained. The study interventions began within 6-12 h of confirmation of diagnosis with RT PCR report and CT scan of thorax (CORAD Score 2-3) of moderate COVID 19. Participants were randomized by the computer-generated random number table and were divided in to two groups: S (Intervention) group and C (control) group. Both the groups received the Covid 19 care as per the hospital treatment protocol. In addition, participants of Group S received Inhaled Budesonide MDI (metered dose inhaler) 2 puff (400mcg) two times in a day for 14 days. All patients were hourly monitored and following parameters were recorded daily for 14 days: GCS, HR, NIBP, SPO2, HR, Temperature, mode of Oxygen therapy: (FM/ VM/ NRBM/ NIV/ IV) and FIO2. Study end point may be before 14 days incase of patient was shifted to ICU due to requirement of mechanical ventilation or incase of adverse outcome within 14 days. Result: The results of this study showed that budesonide nebulization significantly reduced morbidity as there were significant difference between both the group in the number of days requirement of oxygen in Group C 31± 5 days and Group S 7 ± 4 days, number of patient shifted to ICU in Group C 23 and Group S 5 and number of patients expired in Group C 13 and Group S only 4. Discussion is Budesonide is an inhaled glucocorticoid, which inhibits a variety of inflammatory cells, reduces the production of inflammatory mediators and consequently has a significant antiinflammatory effect. Compared to systemic glucocorticoids, budesonide inhalation has the following advantages; high concentration primarily in the lungs, high hepatic clearance, and high glucocorticoid receptor affinity. During nebulization, the nebulizer unit breaks the liquid into micro-particles, which are directly inhaled into the lower respiratory tract and rapidly absorbed by the pulmonary mucosa, thus increasing the local drug concentration. Conclusion: Inhaled budesonide in patient with moderate covid pneumonia..