Abstract

MOLISE, María C.; MAFFEY, Alberto F.; RAMOS, Paula  and  RUBINSTEIN, Fernando. Original salbutamol versus similar salbutamol in children with asthma exacerbation: A randomized, controlled, double-blind study. Arch. argent. pediatr. [online]. 2012, vol.110, n.4, pp.285-290. ISSN 0325-0075.  http://dx.doi.org/10.5546/aap.2012.eng.285.

Introduction.There is clinical evidence suggesting that original salbutamol is more effective than a similar salbutamol product to revert symptoms in acute asthma exacerbation.. Objective. To evaluate the bronchodilator response of both salbutamol medicinal products in children with asthma and to establish, based on the forced expiratory volume, if there is a difference between the group treated with the original salbutamol and the group treated with similar salbutamol. Design. Prospective, randomized, controlled, double-blind study. Material and Methods. One hundred and twenty six children (63 boys, age 9.18 ± 2.83 years old) were included. They were administered a dose of 20 drops (5 mg) of the original salbutamol or similar salbutamol product in nebulizing solution diluted only once in 2 ml saline solution. Preand post-bronchodilator, intra- and inter-group forced expiratory volume was compared at baseline and at 30 minutes. The weight of salbutamol drops was determined by gravimetry, the concentration by chromatography and the number of drops by bottle. Results. The bronchodilator response between the pre- and post-bronchodilator forced expiratory volume was 225 ml (95% CI: 164-286) and 224 ml (95% CI: 163-284) for original salbutamol and similar salbutamol, respectively (p < 0.001). The Delta difference was 1.3 ml (95% CI: -86+83) (p = 0.97). The mean, standard deviation and variation coefficient percentage of the weight of the drop was 364.75 mg (± 6.01, 1.65) and 543.88 mg (± 56.09, 10.31) (p < 0.001) for original salbutamol and similar salbutamol, respectively. Conclusion. There were no differences in the bronchodilator response measured by FEV₁ between the original salbutamol and a similar salbutamol product.

Keywords : Asthma; Beta-adrenergics; Generic drugs; Pulmonary function; Therapeutic equivalence.

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