Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study

Study Overview
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Brief Summary
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Asthma exacerbations account for a significant morbidity and disproportionate health care costs. However, there is no currently available biomarker or lung function parameter that can accurately predict the risk of future exacerbations. The current work aims at evaluating the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS). We hypothesize that monitoring AMARS is potentially able to detect an increased risk of asthma exacerbations.

Detailed Description
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Asthma exacerbations represent an acute or sub-acute worsening in symptoms and lung function from the patient's usual status. Early detection of exacerbations is a major public health issue. In clinic, management of asthma involves asthma control questionnaires and pulmonary function tests (Forced Expiratory Volume (FEV1), Fractional exhaled nitric oxide or FeNO). At home, the peak expiratory flow rate (PEFR) measured by the peak flow meter is an aid to monitor asthma but its ability to predict asthma exacerbations remains controversial. Anharmonic morphological analysis of the respiratory signals (AMARS) is a new morpho-mathematic biomarker that produces objective and accurate measures of the shape of the ventilatory flow. The current study aims at monitoring the resting spontaneous breathing at home in asthmatics. Changes in AMARS may be a predictor of early symptoms of asthma exacerbations. We will recruit 120 asthmatic patients. Patients will be given a portable device for telemonitoring. Resting spontaneous breathing will be measured during 2-3 min in the morning and in the evening, twice a week at least for 12 months. Three visits will be scheduled in Clinical Investigation Center before (V1), after 6-month (V2) and 12-month (V3) telemonitoring period.

Official Title
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Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study

Conditions
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Asthma

Intervention / Treatment
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* Device: anharmonic morphological analysis of the respiratory signals (AMARS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female aged more than 18 yrs written informed consent diagnosis of asthma according to Global Initiative For Asthma (GINA) criteria history of at least one moderate to severe exacerbation in the previous 12 months Exclusion Criteria: smoker or former smoker (> 10 packs-year) concomitant asthma exacerbation (at V1) prisoners protected adults no affiliation to the French Social Security System

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMARS<br>Evaluation the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS). | Device: anharmonic morphological analysis of the respiratory signals (AMARS)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensibility parameters resting breath parameter to predict asthma exacerbation |  | 12 months | 
| Specificity of resting breath parameters to predict asthma exacerbation |  | 12 months | 
| Positive predictive value of resting breath parameters to predict asthma exacerbation |  | 12 months | 
| Negative predictive value of resting breath parameters to predict asthma exacerbation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 | Volume that has been exhaled at the end of the first second of forced expiration | Day 1 | 
| FEV1 | Volume that has been exhaled at the end of the first second of forced expiration | 6 months | 
| FEV1 | Volume that has been exhaled at the end of the first second of forced expiration | 12 months | 
| Asthma exacerbation severity | The number of asthma exacerbations between Day 1 and month 12 will be quoted and defined according to the protocol (abnormal asthma symptoms increase requiring change in asthma medication). Each exacerbation will be quoted according to its severity as mild (requiring increased in inhaled beta2 agonists use for 7 days as assessed by item6 of the Asthma Control Questionnaire (ACQ)), moderate (requiring short course of oral steroid and/or antibiotics) or severe (i.e., requiring hospitalization). | Day 1 | 
| Asthma exacerbation severity | The number of asthma exacerbations between Day 1 and month 12 will be quoted and defined according to the protocol (abnormal asthma symptoms increase requiring change in asthma medication). Each exacerbation will be quoted according to its severity as mild (requiring increased in inhaled beta2 agonists use for 7 days as assessed by item6 of the Asthma Control Questionnaire (ACQ)), moderate (requiring short course of oral steroid and/or antibiotics) or severe (i.e., requiring hospitalization). | 12 months | 
| Asthma quality of life questionnaires |  | Day 1 | 
| Asthma quality of life questionnaires |  | 6 months | 
| Asthma quality of life questionnaires |  | 12 months | 
| Asthma Control Test questionnaires |  | day 1 | 
| Asthma Control Test questionnaires |  | 6 months | 
| Asthma Control Test questionnaires |  | 12 months | 
| Forced Vital Capacity (FVC) | Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort | day 1 | 
| FVC | Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort | 6 months | 
| FVC | Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort | 12 months | 
| FEV1/FVC ratio |  | Day 1 | 
| FEV1/FVC ratio |  | 6 months | 
| FEV1/FVC ratio |  | 12 months | 
| Forced Expiratory Flow (FEF25-75%) | Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled | Day 1 | 
| FEF25-75% | Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled | 6 months | 
| FEF25-75% | Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled | 12 months | 
| PEF | Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter | Day 1 | 
| PEF | Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter | 6 months | 
| PEF | Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Exacerbations, Telemonitoring, Biomarkers