Abstract
Objective
To study whether addition of pidotimod to inhaled corticosteroid (ICS) therapy enhances control in children with persistent asthma, as compared to ICS therapy alone.
Design
Triple-blinded, randomized controlled trial.
Setting
Allergy and Asthma Clinic, Department of Pediatrics, at a tertiary care hospital between May, 2018 and June, 2019.
Patients
79 children (5–12 years) with newly diagnosed persistent asthma as per Global Initiative for Asthma guidelines.
Interventions
Children received 7 mL twice-a-day for 15 day, followed by 7 mL once-a-day for 45 days of either pidotimod (n=39) or placebo (n=40). In addition, both groups received inhaled budesonide via metered dose inhaler and spacer, throughout the study. Children were followed up every 4 weeks for a total of 12 weeks. At each follow-up visit, peak expiratory flow (PEF) and asthma symptom score and medicine adverse effects were recorded.
Main outcome measures
Change in PEF at 12 weeks compared to baseline. Secondary outcomes were PEF at each follow-up visit, asthma symptom score at each visit, change in asthma symptom score at 12 weeks, and adverse event profile.
Results
The median (IQR) change in PEF (from baseline to 12 weeks) was 13.0% (0.8%, 28.3%) in pidotimod group (n=35) vs 17.7% (4.3%, 35.2%) in placebo group (n=35) (P=0.69). All the secondary outcomes were also comparable between the two groups. There were no significant adverse effects observed.
Conclusions
Addition of pidotimod for 8 weeks to standard ICS therapy did not enhance asthma control compared to placebo.
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Acknowledgements
Mr. Deepak Dhawan, Respiratory Technician, Advanced Pediatrics Centre, for performing PEF measurements in the enrolled children. Mrs. Deepika Rechal, Research Nurse, for assistance with enrolment and follow-up of children in this study.
Funding
M/s Wockhardt Limited (Mumbai, India) provided pidotimod and identical placebo, free of cost
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Ethics Clearance
Institute’s Ethics Committee, PGIMER; No. NK/4232/MD/481 dated 20 March, 2018.
Contributors
RD: enrolled patients, collected data, interpreted them, and drafted the manuscript; JLM: conceived and designed the study, supervised data collection, revised and finalized the manuscript. He will act as guarantor of the study; MS: was overall in-charge of patient management and helped in manuscript writing. The final manuscript was approved by all authors.
Competing interest
None stated.
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Deglurkar, R., Mathew, J.L. & Singh, M. Efficacy and Safety of Pidotimod in Persistent Asthma: A Randomized Triple-Blinded Placebo-Controlled Trial. Indian Pediatr 59, 201–205 (2022). https://doi.org/10.1007/s13312-022-2465-x
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DOI: https://doi.org/10.1007/s13312-022-2465-x