Risk Factors Associated to Difficult-to-control Asthma

Rafael Stelmach74 enrolled

Overview

Several studies have demonstrated the efficacy of asthma treatment but despite being correctly diagnosed, conveniently prescribed and adherent to the therapeutics, 5% to 10% of asthmatics do not reach disease control. The aim of this study is to measure asthma control, evaluate inflammatory and functional characteristics, describe comorbidities and aggravating factors and phenotypes derived from the characteristics of a severe asthmatic population followed at an outpatient university service in Sao Paolo, Brazil.

Study design: interventional Patients selection: Seventy-four severe asthma patients, aged between 18 and 65 years old were recruited from the outpatient clinics of the Pulmonary Division of the University of São Paolo Hospital. Severe asthma were defined according to GINA. Intervention: after 2 weeks screening period patients were treated with high inhaled corticosteroid dose plus long acting beta 2 agonist during 12 weeks plus oral corticosteroid ( prednisone 40 mg/day) during 2 weeks. Procedures ( baseline, after 2 weeks and 12 weeks): asthma control questionnaire (ACQ), asthma control (ACT) test, lung function test, quality of life questionnaire (SGRQ and SF-36), exhaled nitric oxide (FeNO), induced sputum (IS). After 12 weeks patients underwent the following evaluation: Upper Digestive Endoscopy, Esophageal 24hs pHmetry, High Resolution Chest Tomography, Nasoscope exam,Bronchofibroscopy with endobronchial biopsy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ASTHMA

Interventions

inhaled corticosteroid plus LABA plus oral corticosteroidDRUG

formoterol plus budesonide 12/400mcg 2times/day and 6/200 mcg as needed and prednisone 40 mcg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18 and 65 years * Diagnosis of moderate to severe asthma (GINA) for at least one year * Presence of airway obstruction reversibility (documented within the last 5 years before the start-up of study) * Smoking, non-smoking or ex-smoking patients of \<30 pack-years. * Need of inhaled corticosteroid (IC),\> or equal 1000mcg of Beclomethasone Dipropionate (DPB) or similar in the last year plus beta 2 long duration agonist in the last year. * At least one exacerbation with the need of oral corticosteroid in the last year. Exclusion Criteria: * Pregnant women; * Co-morbidities that may interfere with the management of the study; * Patients who cannot understand the procedures of the study or who are not able to provide their free and clarified consent; * Patients with other pulmonary diseases which may interfere with the evaluation of the study.

Locations (1)

University of São Paulo - Heart Institute and Hospital das Clínicas

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Asthma control questionnaire (ACQ)

Compare ACQ score in baseline and after 2 weeks of oral plus inhaled corticosteroid plus LABA and after 12 weeks of inhaled corticosteroid plus LABA

Time frame: Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA

Secondary Outcomes

Inflammatory parameters

Compare inflammatory parameters ( FeNO and Induced sputum) at baseline and after 2 weeks of oral plus inhaled corticosteroid plus LABA and after 12 weeks of inhaled corticosteroid plus LABA treatment

Time frame: Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA

Data from ClinicalTrials.gov

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