Risk Factors Associated to Difficult-to-control Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-09

Study Completion Date

2009-05-13

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.

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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.

Conditions

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ASTHMA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label study. All subjects received the same treatment

Study Groups

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Stantardized treament

oral and inhaled corticosteroid plus LABA

Group Type EXPERIMENTAL

inhaled corticosteroid plus LABA plus oral corticosteroid

Intervention Type DRUG

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

Interventions

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inhaled corticosteroid plus LABA plus oral corticosteroid

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

Intervention Type DRUG

Other Intervention Names

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inhaled corticosteroid LABA oral corticosteroid

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No