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Severe AsthmaBRASAFUSPNCT03532685

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

A study testing Bariatric in people with Severe Asthma and Obesity, run by University of Sao Paulo General Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Asthma, Obesity
What is being tested?
Bariatric
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
No sites listed yet
Study dates
May 2018to Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Rafael Stelmach, MD/PHD contact

+551126615695

rafael.stelmach@incor.usp.br

Regina Carvalho-Pinto, MD/PHD contact

+551126615695

regina.carvalho@incor.usp.br

About this study

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

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.

Being tested
Bariatric
Keywords
Asthma, severity, follow up, obesity, bariatric surgery
Medical subject headings
Asthma, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BariatricProcedure or surgery

    withdrawing a part of the stomach and may or may not be combined with bowel deviation

Study groups in NCT03532685
Study groupRoleWhat they receive
Severe Asthma Obese Patients SurgeryActive comparatorBariatric surgery
Receives: Procedure: Bariatric
Severe Asthma Obese PatientsNo interventionusual care
Severe Obese PatientsNo interventionusual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 10 years

  2. 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

    Measured: 6-8 months

Secondary outcomes (7)

  1. Asthma exacerbations - unit: exacerbation/patient/year (number)

    Rate of exacerbations per patient/year

    Measured: up to 10 years

  2. Bronchial thickening measures overtime - unit: Percentage (%) bronchial wall area

    To compare the degree of bronchial thickening, through chest tomography

    Measured: up to 10 years

  3. Morbimortality - unit: number patients/year

    Mortality and Hospitalizations per patient/year

    Measured: up to 10 years

  4. Residual Volume (RV) - Liters

    To compare the degree of air trapping

    Measured: uo to 10 years

  5. Total Lung Capacity (TLC) - Liters

    To compare the degree of air tapping

    Measured: up to 10 years

  6. Ratio Residual Volume/Total Lung Capacity - Percentual (%)

    To compare the degree of air trapping

    Measured: up to 10 years

  7. Nitrogen Washout Test - Percentual (%)

    To compare the heterogeneity amount of small airways

    Measured: up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2018
  2. Study startMay 2018 (estimated)
  3. Primary completionMay 2018 (estimated)
  4. Study completionFeb 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03532685
Sponsor's protocol ID
SDC - 4632/17/132
Other IDs
82357517.0.0000.0068
Acronym
BRASAFUSP
Status last verified
May 2018
First submitted
30 Apr 2018
Last updated
22 May 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21890336

  • 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.

    PubMed 29340498

  • 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.

    PubMed 28960335

  • 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.

    PubMed 28684597

  • 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.

    PubMed 27852260

  • 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.

    PubMed 26487563

  • 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.

    PubMed 24232701

Questions about this trial

What is this clinical trial studying?

A study testing Bariatric in people with Severe Asthma and Obesity, run by University of Sao Paulo General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rafael Stelmach, MD/PHD (+551126615695, rafael.stelmach@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Expiratory Volume first second (FEV1) - Unit: liters (time frame: up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03532685, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.

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