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Risk Factors Associated to Difficult-to-control Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01089322
First Posted: March 18, 2010
Last Update Posted: February 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Rafael Stelmach, University of Sao Paulo General Hospital
February 22, 2010
March 18, 2010
February 16, 2017
December 9, 2005
April 3, 2009   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01089322 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Risk Factors Associated to Difficult-to-control Asthma
Risk Factors Associated to Difficult-to-control Asthma: Characterization of Clinical, Structural and Inflammatory Factors Related to Treatment Response

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.

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.

Interventional
Phase 4
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
Primary Purpose: Treatment
ASTHMA
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:
  • inhaled corticosteroid
  • LABA
  • oral corticosteroid
Experimental: Stantardized treament
oral and inhaled corticosteroid plus LABA
Intervention: Drug: inhaled corticosteroid plus LABA plus oral corticosteroid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
May 13, 2009
April 3, 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01089322
OBSTRUÇÃOHC-02
No
Not Provided
Not Provided
Rafael Stelmach, University of Sao Paulo General Hospital
Rafael Stelmach
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Regina M. Carvalho Pinto, MD Heart Institute - University of São Paulo
Study Director: Rafael Stelmach, PhD Heart Institute - University of São Paulo
University of Sao Paulo General Hospital
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP