Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03532685
Recruitment Status : Not yet recruiting
First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Rafael Stelmach, University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Severe Asthma Obesity Procedure: Bariatric Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Severe Asthma Obese Patients Surgery
Bariatric surgery
Procedure: Bariatric
withdrawing a part of the stomach and may or may not be combined with bowel deviation

No Intervention: Severe Asthma Obese Patients
usual care
No Intervention: Severe Obese Patients
usual care



Primary Outcome Measures :
  1. Forced Expiratory Volume first second (FEV1) - Unit: liters [ Time Frame: up to 10 years ]
    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.

  2. Impulse oscillometry: combined resistance and reactance measures (R5, R20, R5-20) kilopascal - unit: Liters -1/second -1 [ Time Frame: 6-8 months ]
    To evaluate the functional airways characteristics of obese asthmatic patients, compared to non-obese asthmatics, before and after bariatric surgery


Secondary Outcome Measures :
  1. Asthma exacerbations - unit: exacerbation/patient/year (number) [ Time Frame: up to 10 years ]
    Rate of exacerbations per patient/year

  2. Bronchial thickening measures overtime - unit: Percentage (%) bronchial wall area [ Time Frame: up to 10 years ]
    To compare the degree of bronchial thickening, through chest tomography

  3. Morbimortality - unit: number patients/year [ Time Frame: up to 10 years ]
    Mortality and Hospitalizations per patient/year

  4. Residual Volume (RV) - Liters [ Time Frame: uo to 10 years ]
    To compare the degree of air trapping

  5. Total Lung Capacity (TLC) - Liters [ Time Frame: up to 10 years ]
    To compare the degree of air tapping

  6. Ratio Residual Volume/Total Lung Capacity - Percentual (%) [ Time Frame: up to 10 years ]
    To compare the degree of air trapping

  7. Nitrogen Washout Test - Percentual (%) [ Time Frame: up to 10 years ]
    To compare the heterogeneity amount of small airways



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532685


Contacts
Layout table for location contacts
Contact: Rafael Stelmach, MD/PHD +551126615695 rafael.stelmach@incor.usp.br
Contact: Regina Carvalho-Pinto, MD/PHD +551126615695 regina.carvalho@incor.usp.br

Sponsors and Collaborators
University of Sao Paulo General Hospital
AstraZeneca
Investigators
Layout table for investigator information
Study Director: Alberto Cukier, M/D Unversity of Sao Paulo - Pulmonary Division

Publications of Results:

Other Publications:
Layout table for additonal information
Responsible Party: Rafael Stelmach, Assistant Professor - Pulmonary Division - Heart Institute (InCor), University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03532685     History of Changes
Other Study ID Numbers: SDC - 4632/17/132
82357517.0.0000.0068 ( Other Identifier: Plataforma Brasil - Brazil Platform )
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rafael Stelmach, University of Sao Paulo General Hospital:
Asthma
severity
follow up
obesity
bariatric surgery

Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Lung Diseases, Obstructive
Lung Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases