Risk Factors Associated to Difficult-to-control Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Risk Factors Associated to Difficult-to-control Asthma: Characterization of Clinical, Structural and Inflammatory Factors Related to Treatment Response

Conditions
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ASTHMA

Intervention / Treatment
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* Drug: inhaled corticosteroid plus LABA plus oral corticosteroid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stantardized treament<br>oral and inhaled corticosteroid plus LABA | Drug: inhaled corticosteroid plus LABA plus oral corticosteroid<br>* formoterol plus budesonide 12/400mcg 2times/day and 6/200 mcg as needed and prednisone 40 mcg<br>* Other names: oral corticosteroid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SEVERE ASTHMA, RISK FACTORS, CHARACTERIZATION, CLINICAL CONTROL, INFLAMMATORY MARKERS, SEVERE, CONTROL