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Autonomic Nervous System Role in Uncontrolled ASTHMA and the Paucigranulocitic Phenotype (ANASTHMA)

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ClinicalTrials.gov Identifier: NCT02836691
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Universidad de Zaragoza
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
The autonomic nervous system (ANS) plays an important role in asthma, primarily through the parasympathetic (by the cholinergic pathway) promoting bronchoconstriction. Asthma is a chronic inflammatory disease, however, bronchoconstriction is not always caused by bronchial inflammation, as occurs in paucigranulocitic phenotype or noninflammatory asthma. The hypothesis of this project is based on the activation of the parasympathetic nervous system (PNS) would be involved in the pathogenesis of noninflammatory asthma (paucigranulocitic phenotype) and emotional stress and poor control of patients with severe asthma. To determine the ANS involvement in the pathogenesis of paucigranulocItic phenotype in asthma and correlate emotional stress, mediated by the ANS, with uncontrolled severe asthma. 30 asthmatics with different clinical severity (mild, severe controlled and uncontrolled severe) will be recruited , along with a control group of 10 healthy people. Descriptive variables, spirometry, inflammatory parameters (FeNO and inflammatory cell count in induced sputum), blood, saliva, urine and hair to obtain stress markers (glucose, copeptin, prolactin, cortisol) will be collected, and be supplied validated questionnaires of asthma control, quality of life and stress. For monitoring the response of the ANS will be done through an electrocardiogram, recording the heart rate variability (HRV). This analysis is carried out with the collaboration of engineers specialized in the characterization of cardiovascular signals for measuring the ANS.

Condition or disease Intervention/treatment Phase
Asthma Device: EKG (electrocardiogram) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Autonomic Nervous System Role in Uncontrolled ASTHMA and the Paucigranulocitic Phenotype
Study Start Date : May 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : June 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: EKG to Control subjects
healthy controls without asthma or other respiratory disease.
Device: EKG (electrocardiogram)
Analysis of the heart rate variability with an electrocardiogram with a commercial device adapted to asthmatic patients using 12 leads, a respiratory band and a pulseoximeter.

Active Comparator: EKG monitoring Mild asthma
The clinical grade of asthma is assessed in terms of the type of current asthma control (as GEMA Guide 4.0)
Device: EKG (electrocardiogram)
Analysis of the heart rate variability with an electrocardiogram with a commercial device adapted to asthmatic patients using 12 leads, a respiratory band and a pulseoximeter.

Active Comparator: EKG monitoring severe control asthma
The clinical grade of asthma is assessed in terms of the type of current asthma control (as GEMA Guide 4.0)
Device: EKG (electrocardiogram)
Analysis of the heart rate variability with an electrocardiogram with a commercial device adapted to asthmatic patients using 12 leads, a respiratory band and a pulseoximeter.

Active Comparator: EKG monitoring severe uncontrolled asthma
The clinical grade of asthma is assessed in terms of the type of current asthma control (as GEMA Guide 4.0)
Device: EKG (electrocardiogram)
Analysis of the heart rate variability with an electrocardiogram with a commercial device adapted to asthmatic patients using 12 leads, a respiratory band and a pulseoximeter.




Primary Outcome Measures :
  1. Heart rate variability (HRV) [ Time Frame: 2 years ]
    Comparison of heart rate variability (HRV) through an EKG among the group of non-inflammatory asthma (paucigranulocitic) with the rest of inflammatory phenotypes of severe asthma analyzed.


Secondary Outcome Measures :
  1. Stress [ Time Frame: 2 years ]
    Stress will be evaluated with validated questionnaires. Hospital Anxiety and Depression Scale (HADS)

  2. Glucose (mg/dL) [ Time Frame: 2 years ]
    Blood determination of glucose (mg/dl) as biomarker of emotional stress in patients with severe uncontrolled asthma.

  3. copeptin (pmol/L) [ Time Frame: 2 years ]
    Blood determination of copeptin (pmol/L) as biomarker of emotional stress in patients with severe uncontrolled asthma.

  4. Prolactin (ng/mL) [ Time Frame: 2 years ]
    Blood determination of prolactin (ng/mL) as biomarker of emotional stress in patients with severe uncontrolled asthma.

  5. Salivary cortisol (ng/ml) [ Time Frame: 2 years ]
    Salivary determination of cortisol (ng/ml) as biomarker of emotional stress in patients with severe uncontrolled asthma.

  6. Salivary alpha-amylase U/L [ Time Frame: 2 years ]
    Salivary determination of alpha-amylase U/L as biomarker of emotional stress in patients with severe uncontrolled asthma.

  7. Urine cortisol (mcg/24h) [ Time Frame: 24 hours ]
    Urine cortisol (mcg/24h) as biomarker of emotional stress in patients with severe uncontrolled asthma.



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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients of both sexes aged over 16 diagnosed with asthma (according to criteria GEMA 4.0). The diagnosis of asthma is assumed when the patient records stating suggestive previous symptoms of asthma with variable airflow obstruction (determined by spirometry or meter peak flow) or positive bronchodilator test (increase of 12% and 200 ml. of FEV1 after inhalation of a bronchodilator) or positive test to unspecific bronchoconstriction.

Exclusion Criteria:

  • Asthma exacerbations a month before the visit
  • Concomitance of other chronic respiratory diseases (bronchiectasis, fibrosis, etc.)
  • Other important comorbidities in the opinion of investigators example: cardiovascular, endocrinological (especially diabetes, mental retardation, psychiatric or neurological disease relevant systemic inflammatory or immune disease

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): NCT02836691


Locations
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Spain
Lorena Soto-Retes
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Universidad de Zaragoza
Investigators
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Principal Investigator: Lorena Soto-Retes, physician Santa Creu i Sant Pau Hospital
Publications of Results:

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02836691    
Other Study ID Numbers: IIBSP-SNA-2015-87
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Autonomic nervous system
Uncontrolled severe asthma
Paucigranulocitic asthma phenotype
Stress
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases