CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
EKG (electrocardiogram)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02836691
NCT02836691N/ACompleted

Autonomic Nervous System Role in Uncontrolled ASTHMA and the Paucigranulocitic Phenotype

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·interventional·Posted Jul 19, 2016·Updated Feb 17, 2020

In Brief

A clinical study evaluating EKG (electrocardiogram) for Asthma. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesSpain

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 19, 2016
Enrollment StartMay 1, 2016
Primary CompletionMar 1, 2017
Study CompletionJun 26, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.0 years ago

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.