Autonomic Nervous System Role in Uncontrolled ASTHMA and the Paucigranulocitic Phenotype

NCT02836691 | Completed

• 1 other identifier: IIBSP-SNA-2015-87
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Autonomic nervous system; Uncontrolled severe asthma; Paucigranulocitic asthma phenotype; Stress

Outcome Measures

Primary Outcomes (1)

• Heart rate variability (HRV)

  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.

  2 years

Secondary Outcomes (7)

• Stress

  2 years

• Glucose (mg/dL)

  2 years

• copeptin (pmol/L)

  2 years

• Prolactin (ng/mL)

  2 years

• Salivary cortisol (ng/ml)

  2 years

Study Arms (4)

EKG to Control subjects

ACTIVE COMPARATOR

healthy controls without asthma or other respiratory disease.

Device: EKG (electrocardiogram)

EKG monitoring Mild asthma

ACTIVE COMPARATOR

The clinical grade of asthma is assessed in terms of the type of current asthma control (as GEMA Guide 4.0)

Device: EKG (electrocardiogram)

EKG monitoring severe control asthma

ACTIVE COMPARATOR

The clinical grade of asthma is assessed in terms of the type of current asthma control (as GEMA Guide 4.0)

Device: EKG (electrocardiogram)

EKG monitoring severe uncontrolled asthma

ACTIVE COMPARATOR

The clinical grade of asthma is assessed in terms of the type of current asthma control (as GEMA Guide 4.0)

Device: EKG (electrocardiogram)

Interventions

EKG (electrocardiogram) DEVICE

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.

EKG monitoring Mild asthma; EKG monitoring severe control asthma; EKG monitoring severe uncontrolled asthma; EKG to Control subjects

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Universidad de Zaragoza: collaborator

Study Sites (1)

Lorena Soto-Retes

Barcelona, 08025, Spain

Location

Related Publications (16)

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MeSH Terms

Conditions

Asthma

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Lorena Soto-Retes, physician

  Santa Creu i Sant Pau Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: July 19, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 26, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)