Authors
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Universidade Federal de São Paulo-Escola Paulista de Medicina -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2017
INTERVENTION: 58 patients were recruited and divided into two groups: Ciclesonida group (study group) and Hydrocortisone group (control group). In the study group, 31 patients received 3 ciclesonide (480 mcg) at 5, 20 and 40 minutes, making 1440 mcg of this drug and hydrocortisone placebo as sterile powder, diluted in 20 ml of saline solution Intravenous In the placebo group, with 27 patients, 500 mg of hydrocortisone was given intravenously and 3 placebo jets of Ciclesonide spray at 5, 20 and 40 minutes. Both groups received bronchodilators: 50 mcg fenoterol hydrobromide plus 20 mcg ipratropium bromide, 4 jets in 0 minutes, 10 minutes and 20 minutes. These patients were followed for 4 hours. Patients were monitored with cardioscope, noninvasive blood pressure, pulse oximetry. They made spikes and spirometric tests. They underwent clinical evaluations such as pulmonary auscultation, assessment of ascessory musculature, Borg scale. After and during the study, the need for hospitalization was assessed. D27.505.696.663.050.110 E02.880 CONDITION: bronchial asthma crisis predominantly allergic asthma ; J45.0 PRIMARY OUTCOME: Outcome: Clinical improvement.; To evaluate clinical improvement of patients treated with inhaled Ciclesonide in the asthma crisis. We used the Borg scale from 0 to 10, we considered improvement when the patient, after using the medication, reported that their dyspnea had regressed to a number less than or equal to 2.; Physical examination where we evaluated the use of ascessory musculature (sternocleidomastoid) and wheezing the pulmonary auscultation. For this we used a subjective scale of 0 to 3, we considered improvement when there was no more use of ascessory musculature and reduction of wheezing at pulmonary auscultion.; Outcome: Clinical Improvement; ; We found that inhaled Ciclesonide, in high doses, clinically improves patients with acute asthma compared to endovenous corticosteroid hydrocortisone, when we used the Borg scale for dyspnea, pulmonary auscultation and use of ascessory muscle as parameters. Outcome: Spirometric and Peak Flow Parameters.; ; We evaluated the study and control group, consecutively,, consecutively, the volume expired in the first second (FEV1) by spirometry and flow measurements by peak flow equipment.; We expected that in both parameters there would be elevation to reach 70% of predicted for age, sex, weight, height of the patient. Outcome: Spirometric and Peak Flow Parameters.; ; We observed that at the end of the study, in both groups the patients reached 70% predicted for their age, gender, weight and height. SECONDARY OUTCOME: Outcome : Hospitalization rate. ; ; There was no difference between the study group and the control group when we evaluated the hospital admission rate. Outcome : Hospitalization rate. ; Evaluate hospitalization rate after use of inhaled corticosteroid ciclesonide compared with intravenous corticosteroid hydrocortisone in patients with acute asthma crisis Outcome: Evaluate side effects. ; ; ; In both groups there was no difference in side effects. Outcome: Evaluate side effects. ; ; To evaluate adverse effects such as dry mouth, headache, palpitation, tremors and anxiety in the study and control group. INCLUSION CRITERIA: Asthmatic patients aged greater than 13 years, with no upper limit and of both sexes, diagnosed with asthma according to the criteria of the GINA (Global Initiative for Asthma), moderate or severe asthma,that is, with lower FEV1 50 %.
Epistemonikos ID: 2dc0083521afaf8035ba82fc32a5fbd1d505fb1a
First added on: Aug 23, 2024