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Risk Factors Associated to Difficult-to-control Asthma

Primary Purpose

ASTHMA

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

inhaled corticosteroid plus LABA plus oral corticosteroid

About this trial

This is an interventional treatment trial for ASTHMA focused on measuring SEVERE ASTHMA, RISK FACTORS, CHARACTERIZATION, CLINICAL CONTROL, INFLAMMATORY MARKERS, SEVERE, CONTROL

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of São Paulo - Heart Institute and Hospital das Clínicas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stantardized treament

Arm Description

oral and inhaled corticosteroid plus LABA

Outcomes

Primary Outcome Measures

Asthma control questionnaire (ACQ)

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

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

Full Information

NCT ID

NCT01089322

First Posted

February 22, 2010

Last Updated

February 14, 2017

Sponsor

Rafael Stelmach

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01089322

Brief Title

Risk Factors Associated to Difficult-to-control Asthma

Official Title

Risk Factors Associated to Difficult-to-control Asthma: Characterization of Clinical, Structural and Inflammatory Factors Related to Treatment Response

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

December 9, 2005 (Actual)

Primary Completion Date

April 3, 2009 (Actual)

Study Completion Date

May 13, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rafael Stelmach

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ASTHMA

Keywords

SEVERE ASTHMA, RISK FACTORS, CHARACTERIZATION, CLINICAL CONTROL, INFLAMMATORY MARKERS, SEVERE, CONTROL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

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

Allocation

N/A

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stantardized treament

Arm Type

Experimental

Arm Description

oral and inhaled corticosteroid plus LABA

Intervention Type

Drug

Intervention Name(s)

inhaled corticosteroid plus LABA plus oral corticosteroid

Other Intervention Name(s)

inhaled corticosteroid, LABA, oral corticosteroid

Intervention Description

formoterol plus budesonide 12/400mcg 2times/day and 6/200 mcg as needed and prednisone 40 mcg

Primary Outcome Measure Information:

Title

Asthma control questionnaire (ACQ)

Description

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

Time Frame

Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA

Secondary Outcome Measure Information:

Title

Inflammatory parameters

Description

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

Time Frame

Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Regina M. Carvalho Pinto, MD

Organizational Affiliation

Heart Institute, University of São Paulo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rafael Stelmach, PhD

Organizational Affiliation

Heart Institute, University of São Paulo

Official's Role

Study Director

Facility Information:

Facility Name

University of São Paulo - Heart Institute and Hospital das Clínicas

City

São Paulo

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

27852260

Citation

Athanazio R, Carvalho-Pinto R, Fernandes FL, Rached S, Rabe K, Cukier A, Stelmach R. Can severe asthmatic patients achieve asthma control? A systematic approach in patients with difficult to control asthma followed in a specialized clinic. BMC Pulm Med. 2016 Nov 16;16(1):153. doi: 10.1186/s12890-016-0314-1.

Results Reference

derived

PubMed Identifier

21890336

Citation

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.

Results Reference

derived

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Risk Factors Associated to Difficult-to-control Asthma

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