NCT02853578

Busonid® (Budesonide 200 mcg and 400 mcg) to Treat Asthma Not Controlled or Partially Controlled

National Clinical Study, Multicentric, Single Arm to Evaluate the Efficacy and Safety of Busonid® (Budesonide 200 mcg and 400 mcg) to Treat Asthma Not Controlled or Partially Controlled

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Busonid® is composed of budesonide and has two performances of 200mcg and 400mcg. It is a corticosteroid hormone with topical anti-inflammatory activity. The slow and continuous release of budesonide in the airways due to their esterification and their short plasma half life increases the selectivity of the corticosteroid to the airways, in patients with asthma, inhaled corticosteroids have a broad spectrum of anti-inflammatory effects, such as reducing the number of inflammatory cells in the lungs and inhibiting the synthesis and release of cytokines and other inflammatory mediators.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Busonid (budesonide 200mcg and 400mcg)	cartridge containing 60 tablets of 200 mcg or 400 mcg and an inhaler; 1 application (inhalation) of 200mcg every 12 noon (400 mcg / day). During the visits of monitoring (V1 and V2) the doctor in charge assess the need to increase the dose of PSI 400mcg for every 12 hours (800mcg / day); treatment for 12 weeks.

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-10-01
• Completion: 2020-12-01
• First posted: 2016-08-03
• Last updated: 2019-07-08

Locations

5 sites across 1 country: Brazil