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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Centro de Pesquisa do Hospital Nipo Brasileiro
São Paulo, Brazil
Centro de Pesquisa em Pneumologia da Santa Casa de São Paulo
São Paulo, Brazil
Centro Paulista de Investigação Clínica - CEPIC
São Paulo, Brazil
IMA Brasil - Instituto de Medicina Avançada
São Paulo, Brazil
Efficacy of Busonid® (budesonide 200 mcg and 400 mcg) in the treatment of asthma after the initiation of treatment (FEV1)
The absolute change in forced expiratory volume in one second \[FEV1 (L)\], 12 weeks after start of treatment (VF) compared to baseline (V0) was measured by spirometry test.
Time frame: 12 weeks
Evaluate the FEV1 (L) during treatment compared to baseline.
Absolute change of FEV1 (L) during treatment (weeks 4, 8 and 12) compared to baseline (week 0).
Time frame: 4, 8 and 12 weeks
Evaluate the FEV1 (% of predicted) during treatment compared to baseline.
Absolute change of FEV1 (% of predicted) during treatment (weeks 4, 8 and 12) compared to baseline (week 0).
Time frame: 4, 8 and 12 weeks
Evaluate the FEV1 / FVC during treatment compared to baseline.
Absolute change of FEV1 / FVC during treatment (weeks 4, 8 and 12) compared to baseline (week 0).
Time frame: 4, 8 and 12 weeks
Evaluate the peak expiratory flow behavior measured each morning and evening throughout the treatment as compared to baseline.
Absolute variation in peak expiratory flow, measured in the morning and evening, through the peak expiratory flow meter laptop at weeks 2, 4, 6, 8, 10 and 12 relative to baseline morning and evening, which will be measured on the day of V0. The peak expiratory flow of weeks 2, 4, 6, 8, 10 and 12 will be determined by the arithmetic mean of the last seven days prior to the week in review.
Time frame: 2, 4, 6, 8, 10 and 12 weeks
Evaluate the occurrence of nighttime awakenings due to symptoms asthma during treatment.
Nights rate with awakenings due to asthma symptoms, set at 2-week intervals (1 and 2; 3 and 4; 5 and 6; 7 and 8; 9 and 10; 11 and 12), as assessed by daily participant.
Time frame: 12 weeks
Assess the need for use of rescue medication over treatment.
Average number of rescue medication used by jets day set at 2 week intervals (1 and 2; 3 and 4; 5 and 6; 7 and 8; 9 and 10; 11 and 12) as daily participant.
Time frame: 12 weeks
Assess satisfaction to treatment by the investigator and participant search / legal representative throughout the treatment.
Satisfaction with treatment, according to investigator assessment and the research participant / legal representative, expressed by the Visual Analogue Scale.
Time frame: 4, 8 and 12 weeks
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