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