Clinical, Inflammatory and Functional Evaluation of a Population of Severe and Obese Asthmatics: Follow up (BRASAFUSP)
Primary Purpose
Severe Asthma, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bariatric
Sponsored by
About this trial
This is an interventional supportive care trial for Severe Asthma focused on measuring Asthma, severity, follow up, obesity, bariatric surgery
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
No Intervention
Arm Label
Severe Asthma Obese Patients Surgery
Severe Asthma Obese Patients
Severe Obese Patients
Arm Description
Bariatric surgery
usual care
usual care
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Asthma exacerbations - unit: exacerbation/patient/year (number)
Rate of exacerbations per patient/year
Bronchial thickening measures overtime - unit: Percentage (%) bronchial wall area
To compare the degree of bronchial thickening, through chest tomography
Morbimortality - unit: number patients/year
Mortality and Hospitalizations per patient/year
Residual Volume (RV) - Liters
To compare the degree of air trapping
Total Lung Capacity (TLC) - Liters
To compare the degree of air tapping
Ratio Residual Volume/Total Lung Capacity - Percentual (%)
To compare the degree of air trapping
Nitrogen Washout Test - Percentual (%)
To compare the heterogeneity amount of small airways
Full Information
NCT ID
NCT03532685
First Posted
April 30, 2018
Last Updated
May 19, 2018
Sponsor
University of Sao Paulo General Hospital
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT03532685
Brief Title
Clinical, Inflammatory and Functional Evaluation of a Population of Severe and Obese Asthmatics: Follow up
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2018 (Anticipated)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Asthma, Obesity
Keywords
Asthma, severity, follow up, obesity, bariatric surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Severe Asthma Obese Patients Surgery
Arm Type
Active Comparator
Arm Description
Bariatric surgery
Arm Title
Severe Asthma Obese Patients
Arm Type
No Intervention
Arm Description
usual care
Arm Title
Severe Obese Patients
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Procedure
Intervention Name(s)
Bariatric
Intervention Description
withdrawing a part of the stomach and may or may not be combined with bowel deviation
Primary Outcome Measure Information:
Title
Forced Expiratory Volume first second (FEV1) - Unit: liters
Description
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.
Time Frame
up to 10 years
Title
Impulse oscillometry: combined resistance and reactance measures (R5, R20, R5-20) kilopascal - unit: Liters -1/second -1
Description
To evaluate the functional airways characteristics of obese asthmatic patients, compared to non-obese asthmatics, before and after bariatric surgery
Time Frame
6-8 months
Secondary Outcome Measure Information:
Title
Asthma exacerbations - unit: exacerbation/patient/year (number)
Description
Rate of exacerbations per patient/year
Time Frame
up to 10 years
Title
Bronchial thickening measures overtime - unit: Percentage (%) bronchial wall area
Description
To compare the degree of bronchial thickening, through chest tomography
Time Frame
up to 10 years
Title
Morbimortality - unit: number patients/year
Description
Mortality and Hospitalizations per patient/year
Time Frame
up to 10 years
Title
Residual Volume (RV) - Liters
Description
To compare the degree of air trapping
Time Frame
uo to 10 years
Title
Total Lung Capacity (TLC) - Liters
Description
To compare the degree of air tapping
Time Frame
up to 10 years
Title
Ratio Residual Volume/Total Lung Capacity - Percentual (%)
Description
To compare the degree of air trapping
Time Frame
up to 10 years
Title
Nitrogen Washout Test - Percentual (%)
Description
To compare the heterogeneity amount of small airways
Time Frame
up to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Stelmach, MD/PHD
Phone
+551126615695
Email
rafael.stelmach@incor.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Carvalho-Pinto, MD/PHD
Phone
+551126615695
Email
regina.carvalho@incor.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Cukier, M/D
Organizational Affiliation
Unversity of Sao Paulo - Pulmonary Division
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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
background
PubMed Identifier
29340498
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/S1806-37562017000000012. No abstract available.
Results Reference
result
PubMed Identifier
28960335
Citation
Ferreira DS, Carvalho-Pinto RM, Gregorio MG, Annoni R, Teles AM, Buttignol M, Araujo-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 obstruction but not symptom control. Allergy. 2018 Mar;73(3):635-643. doi: 10.1111/all.13323. Epub 2017 Oct 23.
Results Reference
result
PubMed Identifier
28684597
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/japplphysiol.00655.2016. Epub 2017 Jul 6.
Results Reference
result
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
result
PubMed Identifier
26487563
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 and psychosocial symptoms in adult obese asthmatics: protocol of a randomized controlled trial. BMC Pulm Med. 2015 Oct 21;15:124. doi: 10.1186/s12890-015-0111-2.
Results Reference
result
PubMed Identifier
24232701
Citation
Dias-Junior 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.
Results Reference
result
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Clinical, Inflammatory and Functional Evaluation of a Population of Severe and Obese Asthmatics: Follow up
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