Clinical, Inflammatory and Functional Evaluation of a Population of Severe and Obese Asthmatics: Follow up

Obesity Clinical Trial

— BRASAFUSP  

Official title:

Brazilian Severe Asthma Cohort Follow up: Clinical, Inflammatory and Functional Evaluation of a Population of Severe Asthmatics Based in Possible Phenotypes and Pathophysiologic Study of Obesity Association

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03532685
• Other study ID #: SDC - 4632/17/132
• Secondary ID: 82357517.0.0000.
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2018
• Est. completion date: February 2019

Study information

• Verified date: May 2018
• Source: University of Sao Paulo General Hospital
• Contact: Rafael Stelmach, MD/PHD
• Phone: +551126615695
• Email: rafael.stelmach[@]incor.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the study of a population of severe asthmatics, not controlled despite the treatment conducted, it was possible to evidence 5 phenotypic groups of patients. According to the refractoriness of the response to treatment, severe asthma may be phenotype in some distinct groups.Other prospective study found a large proportion of severe asthmatics with persistent airway obstruction, despite optimized treatment and systematic follow-up. Small airway involvement and remodelling, characterized by bronchial muscle thickening, appear to be the main culprits for asthma severity and persistent obstruction in this population.A point of interest in the severe asthmatics cohort was the vast majority were female and there were a considerable number of obese. Recent reviews show that the more consistent division of phenotypes in patients with severe asthma is still based on 3 previously described criteria (presence of atopy, eosinophilia and age of onset of asthma) and a more recent criterion for the presence of multi-comorbidities. Heterogeneity is the rule, the presumption of a natural evolution of gravity is not confirmed and the overlap of clusters is frequent. The stability and natural history of the phenotypes is poorly understood, postulating that the inflammatory activation of the severe asma is multifactorial and may resemble that described in the oncology literature.To date, there are no markers that allow prediction of lung evolution of most patients with severe asthma, and which patients are at greater risk of developing persistent or accelerated loss airflow or lung function, factors determining the severity of asthma. It is also unclear whether and how much phenotype-based treatment impact on disease control and prognosis. Future studies will be instrumental in defining how and why. These phenotypes are evolving, leading to the disabling characteristics of severe asthma and what may be the more effective therapeutic approaches for these patients. Since the initiated research group from 2006 has an extensive clinical, functional, inflammatory, tomographic and morphological evaluation of a cohort of patients with severe asthma, the ideal scenario exists to advance the understanding and investigation of the evolution of this rare disease through standardized follow-up.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: February 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate to severe asthma (GINA step 3-5), followed in the outpatient clinic

• Non-smokers, smokers or former smokers of = 10 packets per year. For smokers, <10 cigarettes / day and with onset asthma before onset of smoking

• Obese asthma patients BMI>30 kg / m2 FEV1 pre bronchodilator between 50 and 80% predicted

• Normal Chest Xray

Exclusion Criteria:

• Pregnancy

• Patients with a history of neoplasia, HIV + or other comorbidities that may interfere in the the study

• Patients with no understanding of the study procedures or who are not able to give their free and informed consent;

• Patients with other lung diseases such as chronic obstructive pulmonary disease, bronchiectasis, cystic fibrosis, or other lung diseases that may interfere with the study evaluation;

• Non adherence to standard asthma treatment;

• Inability to perform lung function assessment tests;

• Pulmonary exacerbation up to 30 days before the first study evaluation

Related Conditions & MeSH terms

• Asthma
• Obesity
• Severe Asthma

Intervention

Procedure:
• Bariatric
withdrawing a part of the stomach and may or may not be combined with bowel deviation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	AstraZeneca

References & Publications (7)

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. 2 — View Citation

Carvalho-Pinto RM, Agondi RC, Giavina-Bianchi P, Cukier A, Stelmach R. Omalizumab in patients with severe uncontrolled asthma: well-defined eligibility criteria to promote asthma control. J Bras Pneumol. 2017 Nov-Dec;43(6):487-489. doi: 10.1590/S1806-3756 — View 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. — View Citation

Dias-Júnior SA, Reis M, de Carvalho-Pinto RM, Stelmach R, Halpern A, Cukier A. Effects of weight loss on asthma control in obese patients with severe asthma. Eur Respir J. 2014 May;43(5):1368-77. doi: 10.1183/09031936.00053413. Epub 2013 Nov 14. — View Citation

Ferreira DS, Carvalho-Pinto RM, Gregório MG, Annoni R, Teles AM, Buttignol M, Araújo-Paulino BB, Katayama EH, Oliveira BL, Del Frari HS, Cukier A, Dolhnikoff M, Stelmach R, Rabe KF, Mauad T. Airway pathology in severe asthma is related to airflow obstruct — View Citation

Ferreira PG, Freitas PD, Silva AG, Porras DC, Stelmach R, Cukier A, Fernandes FLA, Martins MA, Carvalho CRF. Dynamic hyperinflation and exercise limitations in obese asthmatic women. J Appl Physiol (1985). 2017 Sep 1;123(3):585-593. doi: 10.1152/japplphys — View Citation

Freitas PD, Ferreira PG, da Silva A, Trecco S, Stelmach R, Cukier A, Carvalho-Pinto R, Salge JM, Fernandes FL, Mancini MC, Martins MA, Carvalho CR. The effects of exercise training in a weight loss lifestyle intervention on asthma control, quality of life — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume first second (FEV1) - Unit: liters	To assess the rate of loss of lung function in patients with severe asthma, who remain in regular follow - up and under adequate therapy since 2006.	up to 10 years
Primary	Impulse oscillometry: combined resistance and reactance measures (R5, R20, R5-20) kilopascal - unit: Liters -1/second -1	To evaluate the functional airways characteristics of obese asthmatic patients, compared to non-obese asthmatics, before and after bariatric surgery	6-8 months
Secondary	Asthma exacerbations - unit: exacerbation/patient/year (number)	Rate of exacerbations per patient/year	up to 10 years
Secondary	Bronchial thickening measures overtime - unit: Percentage (%) bronchial wall area	To compare the degree of bronchial thickening, through chest tomography	up to 10 years
Secondary	Morbimortality - unit: number patients/year	Mortality and Hospitalizations per patient/year	up to 10 years
Secondary	Residual Volume (RV) - Liters	To compare the degree of air trapping	uo to 10 years
Secondary	Total Lung Capacity (TLC) - Liters	To compare the degree of air tapping	up to 10 years
Secondary	Ratio Residual Volume/Total Lung Capacity - Percentual (%)	To compare the degree of air trapping	up to 10 years
Secondary	Nitrogen Washout Test - Percentual (%)	To compare the heterogeneity amount of small airways	up to 10 years