Busonid® (Budesonide 200 mcg and 400 mcg) to Treat Asthma Not Controlled or Partially Controlled (Laennec)
|ClinicalTrials.gov Identifier: NCT02853578|
Recruitment Status : Suspended (The viability of the study is being analyzed)
First Posted : August 3, 2016
Last Update Posted : July 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Busonid (budesonide 200mcg and 400mcg)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Busonid (budesonide 200mcg and 400mcg)
It´s a capsule with inhalatoin powder composed of budesonide 200mcg or 400mcg. The experimental drug will be dispensed in a cartridge containing 60 capsules of 200 mcg or 400 mcg and an inhaler. It should be stored at room temperature (between 15 and 30°C) and protected from moisture.
Regarding the dosage, the 80 study participants will perform an inhalation 200mcg every 12 hours (400 mcg / day). During follow-up visits (V1 and V2) the attending physician will assess the need for increased PSI dose to 400 mcg every 12 hours (800mcg / day). Study participants should rinse the mouth with water and / or brush your teeth immediately after use of the drug.
The duration of treatment may be 12 weeks.
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.
Other Name: Busonid
- Efficacy of Busonid® (budesonide 200 mcg and 400 mcg) in the treatment of asthma after the initiation of treatment (FEV1) [ Time Frame: 12 weeks ]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.
- Evaluate the FEV1 (L) during treatment compared to baseline. [ Time Frame: 4, 8 and 12 weeks ]Absolute change of FEV1 (L) during treatment (weeks 4, 8 and 12) compared to baseline (week 0).
- Evaluate the FEV1 (% of predicted) during treatment compared to baseline. [ Time Frame: 4, 8 and 12 weeks ]Absolute change of FEV1 (% of predicted) during treatment (weeks 4, 8 and 12) compared to baseline (week 0).
- Evaluate the FEV1 / FVC during treatment compared to baseline. [ Time Frame: 4, 8 and 12 weeks ]Absolute change of FEV1 / FVC during treatment (weeks 4, 8 and 12) compared to baseline (week 0).
- Evaluate the peak expiratory flow behavior measured each morning and evening throughout the treatment as compared to baseline. [ Time Frame: 2, 4, 6, 8, 10 and 12 weeks ]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.
- Evaluate the occurrence of nighttime awakenings due to symptoms asthma during treatment. [ Time Frame: 12 weeks ]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.
- Assess the need for use of rescue medication over treatment. [ Time Frame: 12 weeks ]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.
- Assess satisfaction to treatment by the investigator and participant search / legal representative throughout the treatment. [ Time Frame: 4, 8 and 12 weeks ]Satisfaction with treatment, according to investigator assessment and the research participant / legal representative, expressed by the Visual Analogue Scale.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853578
|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|
|Principal Investigator:||Elie Fiss||Multidisciplinary Studies Center CEPES of the ABC Medical School|