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Risk Factors Associated to Difficult-to-control Asthma

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01089322
First received: February 22, 2010
Last updated: March 16, 2010
Last verified: February 2010

February 22, 2010
March 16, 2010
October 2006
December 2008   (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 ] [ 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
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 ] [ 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
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
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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
single arm
oral and inhaled corticosteroid plus LABA
Intervention: Drug: inhaled corticosteroid plus LABA plus oral corticosteroid
de Carvalho-Pinto RM, Cukier A, Angelini L, Antonangelo L, Mauad T, Dolhnikoff M, Rabe KF, Stelmach R. Clinical characteristics and possible phenotypes of an adult severe asthma population. Respir Med. 2012 Jan;106(1):47-56. doi: 10.1016/j.rmed.2011.08.013. Epub 2011 Sep 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
May 2009
December 2008   (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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01089322
OBSTRUÇÃOHC-02
No
Rafael Stelmach, Hospital das Clínicas - FMUSP
University of Sao Paulo General Hospital
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 2010

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