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

University Hospital, Bordeaux120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

120

Conditions

Asthma

Interventions

anharmonic morphological analysis of the respiratory signals (AMARS)DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Grenoble University Hospital

Grenoble, France

Bordeaux University Hospital

Pessac, France

Outcomes

Primary Outcomes

Sensibility parameters resting breath parameter to predict asthma exacerbation

Time frame: 12 months

Specificity of resting breath parameters to predict asthma exacerbation

Time frame: 12 months

Positive predictive value of resting breath parameters to predict asthma exacerbation

Time frame: 12 months

Negative predictive value of resting breath parameters to predict asthma exacerbation

Time frame: 12 months

Secondary Outcomes

FEV1

Volume that has been exhaled at the end of the first second of forced expiration

Time frame: Day 1

FEV1

Volume that has been exhaled at the end of the first second of forced expiration

Time frame: 6 months

FEV1

Volume that has been exhaled at the end of the first second of forced expiration

Time frame: 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).

Time frame: Day 1

Data from ClinicalTrials.gov

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