Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Positive predictive value of resting breath parameters to predict asthma exacerbation
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Positive predictive value of resting breath parameters to predict asthma exacerbation
Time Frame: 12 months
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
Negative predictive value of resting breath parameters to predict asthma exacerbation
Time Frame: 12 months
Secondary Outcomes
- Forced Vital Capacity (FVC)(day 1)
- Asthma exacerbation severity(12 months)
- PEF(12 months)
- Asthma quality of life questionnaires(12 months)
- Asthma Control Test questionnaires(12 months)
- FEV1/FVC ratio(12 months)
- FEV1(12 months)
- FVC(12 months)
- Forced Expiratory Flow (FEF25-75%)(Day 1)
- FEF25-75%(12 months)