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Efficacy and Safety of Pidotimod in Persistent Asthma: A Randomized Triple-Blinded Placebo-Controlled Trial
Revati Deglurkar1, Joseph L Mathew2, Meenu Singh2
1Department of Pediatrics, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research, Chandigarh.
Insights
Adding pidotimod to inhaled corticosteroid (ICS) therapy did not improve asthma control in children. This study found no significant difference in lung function or symptoms compared to ICS alone.
Area of Science:
- Pediatric Allergy and Immunology
- Respiratory Medicine
- Clinical Pharmacology
Background:
- Persistent asthma in children requires effective management strategies.
- Inhaled corticosteroids (ICS) are a cornerstone of asthma therapy.
- Immunomodulators like pidotimod are explored as adjunctive treatments.
Purpose of the Study:
- To evaluate the efficacy of adding pidotimod to inhaled corticosteroid (ICS) therapy for persistent asthma control in children.
- To compare asthma control metrics between children receiving ICS plus pidotimod versus ICS alone.
Main Methods:
- A triple-blinded, randomized controlled trial was conducted.
- 79 children aged 5-12 years with persistent asthma were enrolled.
- Participants received either pidotimod or placebo alongside standard inhaled budesonide therapy for 12 weeks.
Main Results:
- No significant difference in the primary outcome, change in peak expiratory flow (PEF) at 12 weeks, was observed between the pidotimod and placebo groups (P=0.69).
- Secondary outcomes, including PEF at follow-up visits, asthma symptom scores, and adverse events, were comparable between groups.
- No significant adverse effects were reported in either treatment arm.
Conclusions:
- The addition of pidotimod to standard ICS therapy for 8 weeks did not demonstrate enhanced asthma control in children with persistent asthma.
- Current evidence suggests pidotimod is not superior to placebo when used as an add-on therapy to ICS in this pediatric population.
- Further research may be needed to explore alternative immunomodulatory agents or treatment durations.
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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