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

NCT02853578 | Suspended Phase 3

• 1 other identifier: ACH-BSN-03(14/14)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (7)

• Evaluate the FEV1 (L) during treatment compared to baseline.

  4, 8 and 12 weeks

• Evaluate the FEV1 (% of predicted) during treatment compared to baseline.

  4, 8 and 12 weeks

• Evaluate the FEV1 / FVC during treatment compared to baseline.

  4, 8 and 12 weeks

• Evaluate the peak expiratory flow behavior measured each morning and evening throughout the treatment as compared to baseline.

  2, 4, 6, 8, 10 and 12 weeks

• Evaluate the occurrence of nighttime awakenings due to symptoms asthma during treatment.

  12 weeks

Study Arms (1)

Busonid (budesonide 200mcg and 400mcg)

EXPERIMENTAL

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)

Interventions

Busonid (budesonide 200mcg and 400mcg) DRUG

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.

Also known as: Busonid

Busonid (budesonide 200mcg and 400mcg)

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Uncontrolled asthma diagnosis or partially controlled in according to the Guidelines of the Brazilian Society of Pneumology and Phlebology for Asthma Management - 2012;
• Capacity of survey participants or legal guardians to understand and consent to the participation of the research participant in this clinical study, expressed by signing the informed consent form;
• Ability of children survey participants 18 years understand and nod their participation in this clinical study, manifested by signing the informed assent form;
• Baseline forced expiratory volume in one second in screening visit between 55% and 85% of predicted value (before bronchodilator use), including the extremes (ensuring that the lung function test has been performed properly);
• Increase of 12% and 200 ml of forced expiratory volume in one second after the reversibility test at screening visit / initiation of treatment.

You may not qualify if:

• Diagnosis of pneumonia, pneumothorax, pneumomediastinum, COPD, pulmonary tuberculosis, deficiency α1anti antitrypsin, lung mycosis (blastomycosis, histoplasmosis), bronchiectasis, pulmonary cystic fibrosis or other significant respiratory disease, according to the investigator;
• Pneumothorax history, pulmonary tuberculosis, lung mycosis (blastomycosis, histoplasmosis) and COPD;
• Immunosuppressive therapy;
• Survey participants with immunosuppression of any kind;
• Thoracic surgery history or any prior neoplastic process of the lung;
• Significant heart disease;
• Four or more systemic corticosteroid courses in the last 12 months;
• Participants who have needed hospitalization or care in the emergency room or emergency service (duration\> 12 hours) to airway obstruction control (for exacerbation of asthma), at least once within the last three (03) months;
• History of asthma crisis with risk of death;
• Ventilatory support needs due to respiratory failure secondary to asthma within the past five (05) years;
• Infection of the upper respiratory tract or lower (viral or bacterial) within the last four (04) weeks prior to study entry;
• Any finding of clinical observation (clinical evaluation / physical) that is interpreted by the medical researcher as a risk to the research participant in the clinical study;
• Known hypersensitivity to drug components used during the study;
• Use of forbidden drugs in the clinical study described in Protocol;
• Smokers and former smokers;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (5)

Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Location

Centro de Pesquisa do Hospital Nipo Brasileiro

São Paulo, Brazil

Location

Centro de Pesquisa em Pneumologia da Santa Casa de São Paulo

São Paulo, Brazil

Location

Centro Paulista de Investigação Clínica - CEPIC

São Paulo, Brazil

Location

IMA Brasil - Instituto de Medicina Avançada

São Paulo, Brazil

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Elie Fiss

  Multidisciplinary Studies Center CEPES of the ABC Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 3, 2016
• Study Start: December 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

BR (5)