Ten otherwise healthy pediatric patients, 8 females and 2 males, with exercise-induced asthma (EIA) were included in this study comparing the prophylactic use of Lagundi syrup and terbutaline. Baseline Forced Expiratory Volume/minute (FEV1) values were measured.
Five subjects were assigned to each of the two treatment groups, with the drugs being given for 7 days three times daily. Efficacy of treatment was assessed by measuring individual FEV1 values after a 6 minute free running exercise challenge, 30 minutes after the last dose of the drugs being tested. All the subjects in the Lagundi therapy (45 mg/kg/day) showed improvement from pre-treatment percentage fall in FEV1 while only 2 of the five subjects given terbutaline improved. However only 4/5 of the lagundi-treated could be considered to have a positive clinical response (% fall in FEV1) of less than 15% after an exercise challenge.
Another basis for drug effect was PEFR (Peak expiratory flow rate) taken at 8:00 AM and 8:00 PM, as an indicator of airway lability which was also done by the volunteer subjects. A decrease in % change in PEFR was taken to indicate a reduction in airway lability or an indicator of airway stability. In the lagundi treatment group, four of the five subjects showed less airway lability while only 2 of the 4 subjects treated with terbutaline responded similarly (one subject showed poor compliance and not considered in the terbutaline group for PEFR evaluation).
Regarding adverse event initial transient drowsiness was reported by those taking lagundi which disappeared with repeated use.
Lagundi syrup demonstrated efficacy and safety as a prophylactic agent for EIA in pediatric patients. Further studies are recommended to be conducted to explore this significant effect of lagundi syrup for asthmatic pediatric patients with exercise-induced asthma and labile PEFR. (Author)
Clinical test done in lagundi syrup as antiasthma. Technology transfer document is already prepared for commercialization research.