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

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 |
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. |
- 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.
- Stress [ Time Frame: 2 years ]Stress will be evaluated with validated questionnaires. Hospital Anxiety and Depression Scale (HADS)
- Glucose (mg/dL) [ Time Frame: 2 years ]Blood determination of glucose (mg/dl) as biomarker of emotional stress in patients with severe uncontrolled asthma.
- copeptin (pmol/L) [ Time Frame: 2 years ]Blood determination of copeptin (pmol/L) as biomarker of emotional stress in patients with severe uncontrolled asthma.
- Prolactin (ng/mL) [ Time Frame: 2 years ]Blood determination of prolactin (ng/mL) as biomarker of emotional stress in patients with severe uncontrolled asthma.
- 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.
- 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.
- 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 |
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

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
Spain | |
Lorena Soto-Retes | |
Barcelona, Spain, 08025 |
Principal Investigator: | Lorena Soto-Retes, physician | Santa Creu i Sant Pau Hospital |
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 |
Autonomic nervous system Uncontrolled severe asthma Paucigranulocitic asthma phenotype Stress |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |