Treating asthmatic children to prevent asthma exacerbations

Phase 4

• Conditions: Mild persistent asthma

• Registration Number: RBR-3gbyhk
• Lead Sponsor: Secretaria Municipal de Saúde de Belo Horizonte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-27
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients of both sexes aged six to eighteen years old, able to perform spirometry, suffering from mild persistent asthma in the past two years according to the criteria of the GINA (Global Strategy for Asthma) and fall into at least one of the following criteria: never used inhaled corticosteroids , anti - leukotrienes , beta- agonists, long-acting and report occurrence of exacerbations in the last two years, but none in the last three months; be in use of inhaled corticosteroids in the past eight weeks, at a daily dose equal to or greater than 250 mcg / day of beclomethasone; be well controlled in the last eight weeks with the use of 250 mcg of beclomethasone and no smoking during the last year.

Exclusion Criteria

Treatment with other formulations of corticosteroids for any condition within the range defined prior to recruitment, e.g., oral route two weeks prior to the period of run in or parenteral route within two weeks of screening visits; previous or current use of medication known to interact with the bioavailability of beclomethasone within a period of two weeks from the first follow up visit , namely , carbamazepine , erythromycin or other macrolide , phenobarbital , phenytoin , rifampin and ketoconazole; Spirometry showing pre bronchodilator FEV1 (forced expiratory volume in one second) less than 60 % of predicted value at first follow visit; hospitalization for asthma in the last year ; presence of other chronic or active disease other than asthma , namely , thyroid disease , diabetes mellitus , Cushing's disease , Addison's disease , liver disease or current medical conditions requiring oral corticosteroid therapy , history of cataract, glaucoma or any other condition medical associated with possible adverse effect of systemic corticosteroids ; asthma exacerbation in the last three months or more than two in the last year ; history of an exacerbation that required intubation , mechanical ventilation or seizure resulting in hypoxia ; previous history of adverse reactions to inhaled corticosteroids ; use of oral or injectable vaccines for for three months or more ; inability to perform spirometry and exhaled nitric oxide ; subjective impression of the researchers that the family or patient will not adhere to treatment or may be transferred from the influence area of a Secondary Reference Units, namely, Campos Sales , Saudade , and Padre Eustáquio outpatient clinic.
Individuals who do not qualify to enter the run in period for reasons that can be overcome with time and training may be admitted to study at a later time.

Study & Design

• Study Type: Intervention
• Study Design: Not specified