Busonid® (Budesonide 200 mcg and 400 mcg) to Treat Asthma Not Controlled or Partially Controlled
Status:
Suspended
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
National clinical trial, phase III, multicenter, single-arm, efficacy study, 80 participants
of both sexes, aged equal or more than 12 and less than 65 years. The group will use Busonid®
(budesonide 200mcg and 400mcg) one application (inhalation) of 200 mcg every 12 hours (400mcg
/ day). During follow-up visits if the participant has not shown an increase in forced
expiratory volume in one second greater than 12% and greater than 0,20L or 200ml in
spirometry compared with baseline visit, will increase the dose to 800 mcg / day (2x 400 mcg
day).
The study aims to revalidate by the National Health Surveillance Agency (ANVISA) the
registration of the drug Busonid® which there is a vast scientific literature on the
pre-clinical and clinical evidence that the efficacy and safety of budesonide. Thus, outlined
is a single-arm study, which is applied to the study of the group of participants the same
intervention for a certain period and the participants are evaluated for response.