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

University Hospital of Bordeaux

Status: Completed

Conditions: Asthma

Treatments: Device: anharmonic morphological analysis of the respiratory signals (AMARS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02990247

CHUBX 2015/04

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

AMARS

Experimental group

Description:

Evaluation the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS).

Treatment:

Device: anharmonic morphological analysis of the respiratory signals (AMARS)