Effectiveness of budesonide formoterol fixed-dose combination MDI in reducing cough symptoms in COVID-19 patients: A real-world evidence study
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.
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, this trial uses multiple treatments in the treatment arm (combined with formoterol) - results of individual treatments may vary.
Abstract: Original Article
CX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdtwnfKZBYtws= on 03/07/2023
Effectiveness of budesonide formoterol fixed‑dose
combination MDI in reducing cough symptoms in
COVID‑19 patients: A real‑world evidence study
Shambo Samrat Samajdar1, Shatavisa Mukherjee2, Saibal Moitra3, Jyotirmoy Pal4, Shashank Joshi5,
Santanu Kumar Tripathi6
Consultant at Diabetes and Allergy-Asthma Specialty Clinic, Kolkata & Clinical Pharmacologist at School of Tropical Medicine, Kolkata,
West Bengal, India, 2Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal, India,
Department of Respiratory Medicine, Division of Allergy and Immunology, Apollo Multispeciality Hospital, Kolkata, West Bengal,
India, 4Department of Medicine, R G Kar Medical College and Hospital, Kolkata, West Bengal, India, 5Department of Diabetology and
Endocrinology, Joshi Clinic, Lilavati Hospital and Research Centre, Mumbai, Maharashtra, India, 6Department of Pharmacology, Netaji
Subhas Medical College and Hospital, Patna, Bihar, India
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.
KEY WORDS: Budesonide formoterol fixed‑dose combination MDI, cough symptoms, COVID‑19
Address for correspondence: Dr. Shambo Samrat Samajdar, Consultant at Diabetes and Allergy-Asthma Specialty Clinic, Kolkata and Clinical Pharmacologist
at School of Tropical Medicine, Kolkata, West Bengal, India.
is less effective
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