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: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ache Laboratorios Farmaceuticos S.A.
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• HIV infection, whether on antiretroviral treatment;

• History of abuse of illicit drugs;

• Disorders diagnosis of hypothalamic-pituitary-adrenal axis (hypocortisolism or hypercortisolism);

• Presence of severe obstruction of lung airflow that may present a risk of death;

• Women in reproductive age who do not agree to use hormonal or barrier methods of contraception; except the participants declared that they perform sexual practices or exercise them not to reproductive form;

• Female participants in a period of pregnancy or breastfeeding;

• Clinical trial protocols of participation in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to it;

• Family relationship to the second degree or bond with employees or employees of Sponsor and Research Center.