Clinical trial NCT01089322: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: ASTHMA
Keywords: SEVERE ASTHMA
RISK FACTORS
CHARACTERIZATION
CLINICAL CONTROL
INFLAMMATORY MARKERS
SEVERE
CONTROL
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2010-03-18
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Asthma control questionnaire (ACQ)
timeFrame: Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA
Secondary outcomes:
measure: Inflammatory parameters
timeFrame: Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo - Heart Institute and Hospital das Clínicas
Study officials:
affiliation: Heart Institute, University of São Paulo
name: Regina M. Carvalho Pinto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute, University of São Paulo
name: Rafael Stelmach, PhD
role: STUDY_DIRECTOR
References:
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.
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.