Risk Factors Associated to Difficult-to-control Asthma

ASTHMA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089322
• Other study ID #: OBSTRUÇÃOHC-02
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2010
• Last updated: February 14, 2017
• Start date: December 9, 2005
• Est. completion date: May 13, 2009

Study information

• Verified date: February 2017
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 13, 2009
• Est. primary completion date: April 3, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• ASTHMA

Intervention

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

Locations

Country	Name	City	State
Brazil	University of São Paulo - Heart Institute and Hospital das Clínicas	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Rafael Stelmach	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA
Secondary	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	Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA