ASTHMA
Conditions
Keywords
SEVERE ASTHMA, RISK FACTORS, CHARACTERIZATION, CLINICAL CONTROL, INFLAMMATORY MARKERS, SEVERE, CONTROL
Brief summary
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.
Detailed description
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.
Interventions
DRUGinhaled corticosteroid plus LABA plus oral corticosteroid
formoterol plus budesonide 12/400mcg 2times/day and 6/200 mcg as needed and prednisone 40 mcg
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Rafael Stelmach
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label study. All subjects received the same treatment
Intervention model description
Retrospective analysis after treatment outcome (controlled vs. non controlled) based on the primary outcome; and post hoc analysis after oral steroid treatment based on pulmonary function reversibility
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma control questionnaire (ACQ) | Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory parameters | Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA | 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 |
Countries
Brazil
Outcome results
None listed