Abstract
Objectives
To compare median change in morning peak expiratory flow rate (PEFR) and clinical asthma control in children receiving total daily dosage of inhaled budesonide administered either as once-daily or divided twice-daily dose.
Methods
It was a randomized, parallel group, open label, noninferiority trial on 80 children aged 5–12 y with mild or moderate well-controlled asthma. Baseline parameters were recorded and subjects received inhaled budesonide either as once-daily or divided twice-daily dose. Primary outcome was median change in morning PEFR. Secondary outcomes included median change in evening and diurnal variation in PEFR, asthma symptom control as per Global Initiative for Asthma, 2017 and Asthma Control Questionnaire, and spirometric measurements taken at the clinic.
Results
The median [interquartile range (IQR)] increase in morning PEFR was more in children receiving once-daily as compared to those receiving twice-daily inhaled budesonide (by 6:00 L/min; IQR: −44.00–63.00 L/min vs. 4:00 L/min; IQR: −67.50–67.50 L/min, p 0.222; 95% CI: −1.37 to 19.08). Other spirometric variables and symptoms scores were also nonsignificant except median change in evening PEFR which was in favor of twice-daily regimen.
Conclusion
Once-daily administration of inhaled budesonide is noninferior to twice-daily administration of equivalent daily dosage of inhaled budesonide.
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Data Availability
Available.
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MG: Acquisition of data; MG, PK: Analysis and interpretation of data; MG, PK, SR: Drafting of the manuscript; VG, PK: Conception and design; VG, PK, SR: Critical revision of the manuscript for important intellectual content; MG, VG, PK, SR: Final approval of the version to be published and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. VG will act as guarantor for this paper.
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The study was conducted in line with the ethical guidelines for biomedical research on human subjects as given by Central Ethics Committee on Human Research (CECHR), ICMR, New Delhi, 2006, and followed the tenets of Declaration of Helsinki, 2008. The trial was approved by the Institutional Ethics Committee, Government Medical College and Hospital, Chandigarh, India (Date: 08.12.2017).
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Written informed consent was obtained from parents or legal guardian.
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Goyal, M., Guglani, V., Kumar, P. et al. Once-Daily vs. Twice-Daily Administration of Inhaled Budesonide for Mild and Moderate Well-Controlled Childhood Asthma: A Randomized, Controlled Trial. Indian J Pediatr 89, 13–18 (2022). https://doi.org/10.1007/s12098-021-03753-1
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DOI: https://doi.org/10.1007/s12098-021-03753-1