Risk Factors Associated to Difficult-to-control Asthma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: inhaled corticosteroid plus LABA plus oral corticosteroid |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Risk Factors Associated to Difficult-to-control Asthma: Characterization of Clinical, Structural and Inflammatory Factors Related to Treatment Response |
- Asthma control questionnaire (ACQ) [ Time Frame: Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA ] [ Designated as safety issue: No ]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
- Inflammatory parameters [ Time Frame: Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA ] [ Designated as safety issue: No ]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
| Enrollment: | 74 |
| Study Start Date: | October 2006 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
single arm
oral and inhaled corticosteroid plus LABA
|
Drug: inhaled corticosteroid plus LABA plus oral corticosteroid
formoterol plus budesonide 12/400mcg 2times/day and 6/200 mcg as needed and prednisone 40 mcg
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| Brazil | |
| University of São Paulo - Heart Institute and Hospital das Clínicas | |
| São Paulo, Brazil | |
| Principal Investigator: | Regina M. Carvalho Pinto, MD | Heart Institute - University of São Paulo |
| Study Director: | Rafael Stelmach, PhD | Heart Institute - University of São Paulo |
More Information
No publications provided by University of Sao Paulo General Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rafael Stelmach, Hospital das Clínicas - FMUSP |
| ClinicalTrials.gov Identifier: | NCT01089322 History of Changes |
| Other Study ID Numbers: | OBSTRUÇÃOHC-02 |
| Study First Received: | February 22, 2010 |
| Last Updated: | March 16, 2010 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by University of Sao Paulo General Hospital:
|
SEVERE ASTHMA RISK FACTORS CHARACTERIZATION CLINICAL CONTROL |
INFLAMMATORY MARKERS SEVERE CONTROL |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013