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Effectiveness of budesonide formoterol fixed-dose combination MDI in reducing cough symptoms in COVID-19 patients: A real-world evidence study

Samajdar et al., Lung India, doi:10.4103/lungindia.lungindia_268_22
Mar 2023  
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Mortality 58% Improvement Relative Risk Ventilation 65% Hospitalization 69% Cough score, day 7 29% Cough score, day 3 10% Budesonide  Samajdar et al.  LATE TREATMENT Is late treatment with budesonide + formoterol beneficial for COVID-19? Prospective study of 102 patients in India (January - June 2021) Improved recovery with budesonide + formoterol (p=0.0082) c19early.org Samajdar et al., Lung India, March 2023 Favorsbudesonide Favorscontrol 0 0.5 1 1.5 2+
Budesonide for COVID-19
19th treatment shown to reduce risk in April 2021, now with p = 0.0000011 from 15 studies, recognized in 8 countries.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
Prospective study of 102 patients in India, showing improved recovery of cough with budesonide+formoterol. Authors note better results with earlier treatment. Budesonide 800mcg + formoterol 12mcg bid for 7 days.
Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects (early treatment may be more beneficial).
risk of death, 58.4% lower, RR 0.42, p = 0.44, treatment 2 of 50 (4.0%), control 5 of 52 (9.6%), NNT 18.
risk of mechanical ventilation, 65.3% lower, RR 0.35, p = 0.62, treatment 1 of 50 (2.0%), control 3 of 52 (5.8%), NNT 27.
risk of hospitalization, 68.8% lower, RR 0.31, p = 0.07, treatment 3 of 50 (6.0%), control 10 of 52 (19.2%), NNT 7.6.
cough score, 29.4% lower, RR 0.71, p = 0.008, treatment mean 2.14 (±1.24) n=50, control mean 3.03 (±1.99) n=52, day 7.
cough score, 9.9% lower, RR 0.90, p = 0.10, treatment mean 4.66 (±1.42) n=50, control mean 5.17 (±1.65) n=52, day 3.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Samajdar et al., 3 Mar 2023, prospective, India, peer-reviewed, mean age 47.2, 6 authors, study period January 2021 - June 2021, average treatment delay 5.98 days, this trial uses multiple treatments in the treatment arm (combined with formoterol) - results of individual treatments may vary. Contact: shambo_sa2001@yahoo.co.in.
This PaperBudesonideAll
Effectiveness of budesonide formoterol fixed-dose combination MDI in reducing cough symptoms in COVID-19 patients: A real-world evidence study
Shambosamrat Samajdar, Shatavisa Mukherjee, Saibal Moitra, Jyotirmoy Pal, Shashank Joshi, Santanukumar Tripathi
Lung India, doi:10.4103/lungindia.lungindia_268_22
Background: Cough is a wearisome and exasperating symptom affecting the daily life of the infected patient. Cough due to coronavirus disease 2019 (COVID-19) causes excessive morbidity in human populations globally. Apart from the morbidity associated with cough, it also enhances the transmission of this viral infection through droplets. Therefore, curbing cough is crucial to limit its spread. Patients often administer over-the-counter products and antitussive agents, which have no proven benefit. The present study was undertaken to find out if cough associated with COVID-19 and other indicative clinical outcomes is alleviated with a budesonide/formoterol fixed-dose combination (FDC) metered-dose inhaler (MDI). Materials and Methods: A prospective observational study was conducted in mild COVID-19 patients who presented with a cough score ≥8 at presentation. Patients who were initiated on ICS-LABA MDI were observed as group A and those who were not initiated on MDI were observed as Group B. Cough symptom score (at baseline and on day 3 and day 7), the incidence of hospital admission and/or death, and need for mechanical ventilation were documented. Prescribing patterns of anti-cough medications were also noted and analysed. Results: Compared to group B, a higher mean cough score reduction was noted for group A patients at day 3 and day 7 when compared to the baseline, and this was significant at P < 0.001. A significant negative correlation was also observed between mean latency of MDI initiation from the symptom onset and mean cough score reduction. Analysis of the proportion of patients prescribed medications to treat cough showed that overall, 10.78% did not require these, with a greater proportion in group A compared to group B. Conclusion: Patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) COVID-19 who were treated with ICS-LABA MDI along with usual care benefitted significantly in terms of symptom reduction compared to usual care.
Ethical approval The study has been approved by the Ethics Committee vide letter no HREC-AARC/13. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
References
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Late treatment
is less effective
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