Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study
- Conditions
- Asthma
- Interventions
- Device: anharmonic morphological analysis of the respiratory signals (AMARS)
- Registration Number
- NCT02990247
- Lead Sponsor
- University Hospital, Bordeaux
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- smoker or former smoker (> 10 packs-year)
- concomitant asthma exacerbation (at V1)
- prisoners
- protected adults
- no affiliation to the French Social Security System
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AMARS anharmonic morphological analysis of the respiratory signals (AMARS) Evaluation the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS).
- Primary Outcome Measures
Name Time Method Negative predictive value of resting breath parameters to predict asthma exacerbation 12 months Positive predictive value of resting breath parameters to predict asthma exacerbation 12 months Sensibility parameters resting breath parameter to predict asthma exacerbation 12 months Specificity of resting breath parameters to predict asthma exacerbation 12 months
- Secondary Outcome Measures
Name Time Method FEF25-75% 12 months Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled
Forced Vital Capacity (FVC) day 1 Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
Asthma exacerbation severity 12 months 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).
PEF 12 months Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter
Asthma quality of life questionnaires 12 months Asthma Control Test questionnaires 12 months FEV1/FVC ratio 12 months FEV1 12 months Volume that has been exhaled at the end of the first second of forced expiration
FVC 12 months Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
Forced Expiratory Flow (FEF25-75%) Day 1 Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled
Trial Locations
- Locations (2)
Bordeaux University Hospital
🇫🇷Pessac, France
Grenoble University Hospital
🇫🇷Grenoble, France