Risk Factors Associated to Difficult-to-control Asthma
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|ClinicalTrials.gov Identifier: NCT01089322|
Recruitment Status : Completed
First Posted : March 18, 2010
Last Update Posted : February 16, 2017
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 or disease||Intervention/treatment||Phase|
|ASTHMA||Drug: inhaled corticosteroid plus LABA plus oral corticosteroid||Phase 4|
Study design: interventional
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 (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Masking:||None (Open Label)|
|Masking Description:||Open label study. All subjects received the same treatment|
|Official Title:||Risk Factors Associated to Difficult-to-control Asthma: Characterization of Clinical, Structural and Inflammatory Factors Related to Treatment Response|
|Actual Study Start Date :||December 9, 2005|
|Actual Primary Completion Date :||April 3, 2009|
|Actual Study Completion Date :||May 13, 2009|
Experimental: Stantardized treament
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
- Asthma control questionnaire (ACQ) [ Time Frame: 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
- Inflammatory parameters [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089322
|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|