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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
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

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

    First Posted
    April 30, 2018
    Last Updated
    May 19, 2018
    Sponsor
    University of Sao Paulo General Hospital
    Collaborators
    AstraZeneca
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    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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