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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 (Responsible Party):
Rafael Stelmach, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01089322
First received: February 22, 2010
Last updated: February 14, 2017
Last verified: February 2017
  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: 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: No masking
Masking Description:
Open label study. All subjects received the same treatment
Primary Purpose: Treatment
Official Title: Risk Factors Associated to Difficult-to-control Asthma: Characterization of Clinical, Structural and Inflammatory Factors Related to Treatment Response

Resource links provided by NLM:


Further study details as provided by Rafael Stelmach, University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 74
Actual Study Start Date: December 9, 2005
Study Completion Date: May 13, 2009
Primary Completion Date: April 3, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • inhaled corticosteroid
  • LABA
  • oral corticosteroid

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   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089322

Locations
Brazil
University of São Paulo - Heart Institute and Hospital das Clínicas
São Paulo, Brazil
Sponsors and Collaborators
Rafael Stelmach
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rafael Stelmach, MD-PHD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01089322     History of Changes
Other Study ID Numbers: OBSTRUÇÃOHC-02
Study First Received: February 22, 2010
Last Updated: February 14, 2017

Keywords provided by Rafael Stelmach, 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 July 24, 2017