Nebulised cromoglycate, theophylline, and placebo in preschool asthmatic children

Area of Science:

• Pediatric Pulmonology
• Clinical Pharmacology
• Allergy and Immunology

Background:

• Chronic asthma affects young children, necessitating safe and effective treatment options.
• Oral choline theophyllinate and nebulised sodium cromoglycate are potential therapies for pediatric asthma.
• Evaluating the efficacy and safety of these treatments in a controlled trial is crucial.

Purpose of the Study:

• To compare the efficacy of oral choline theophyllinate and nebulised sodium cromoglycate in managing chronic asthma in children under 5 years.
• To assess the safety and tolerability of both treatment regimens.
• To determine if either active treatment is superior to placebo in improving asthma symptoms and daily activities.

Main Methods:

• A double-blind, crossover trial involving 16 children aged under 5 years with chronic asthma.
• Three 8-week treatment periods with random administration of active sodium cromoglycate, active choline theophyllinate, and placebo.
• Symptom assessment included sleep disturbance, cough, wheeze, and daily activities.

Main Results:

• Overall symptom scores were similar across all three treatment periods when analyzed with Friedman's test.
• The Mantel-Haenszel test indicated that sodium cromoglycate was significantly superior to placebo (P < 0.05) in maintaining normal daily activities.
• Both choline theophyllinate and sodium cromoglycate were found to be safe and well-tolerated by the pediatric participants.

Conclusions:

• Nebulised sodium cromoglycate demonstrated a statistically significant benefit over placebo in preserving daily function in young children with chronic asthma.
• Oral choline theophyllinate and nebulised sodium cromoglycate represent safe and well-tolerated therapeutic options for pediatric asthma management.
• Further research may explore long-term efficacy and comparative effectiveness of these agents in diverse pediatric asthma populations.