Resumen

ESQUIVEL, Florencia et al. Randomized, Crossover, Non-Inferiority Study to Evaluate the Efficacy, Safety and Tolerability of Two Budenoside/ Formoterol Fumarate Formulations in Asthmatic Adults. Rev. am. med. respir. [online]. 2022, vol.22, n.4, pp.370-382. ISSN 1852-236X.  http://dx.doi.org/10.56538/ramr.abrv4728.

Asthma is a serious worldwide health problem. According to the last report of the Min istry of Health, 1,380,000 subjects suffer from asthma in Argentina. The International Guidelines (Europe, United States, WHO [World Health Organization]) have varying approaches to define equivalence considerations and the possibility of switching orally inhaled products. Whereas an in vitro approach is possible, in general the Guidelines recommend providing more clinical evidence that supports the possibility of switching from the innovative product to another one subsequently developed with the same ac tive principles in the form of dry powder inhaler. This randomized, phase IV study has been conducted to establish the efficacy, safety and tolerability of Neumoterol® 400 compared to the reference medicinal product Symbicort forte, budenoside/formoterol fumarate 320/9 μg twice daily in asthmatic patients. Also, the patients’ preference on the use of the devices has been evaluated.

The evaluated formulation has proven to be non-inferior compared to the reference medicinal product. The lower limit of the 95% CI (confidence interval) for the treat ment difference was greater than the prespecified non-inferiority margin of -125 mL (difference: 0.044 l [95% CI: -0.008 to 0.096]). Also, higher values were evidenced for the AUC0-10h (area under the curve) of the FEV1 (forced expiratory volume in the first second) and a more important change of the baseline score in the asthma control test on day 29 for the budenoside/formoterol fumarate capsules of 400/12 μg. In one exploratory test about the patients’ preference on the use of the devices, a higher pro portion of participants expressed their global preference for the budenoside/formoterol fumarate capsule of 400/12 μg. No differences were reported in the incidence of AEs (adverse events) or SAEs (serious adverse events) during or after the treatment. The safety profile of both products in general coincides with the verified profile of budeno side/formoterol fumarate.

Palabras clave : Asthma; Budenoside; Formoterol fumarate; Inhalation device.

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