Clinical trial NCT02990247: Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study
Official title: Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Exacerbations
Telemonitoring
Biomarkers
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Sensibility parameters resting breath parameter to predict asthma exacerbation
timeFrame: 12 months
measure: Specificity of resting breath parameters to predict asthma exacerbation
timeFrame: 12 months
measure: Positive predictive value of resting breath parameters to predict asthma exacerbation
timeFrame: 12 months
measure: Negative predictive value of resting breath parameters to predict asthma exacerbation
timeFrame: 12 months
Secondary outcomes:
measure: FEV1
timeFrame: Day 1
measure: FEV1
timeFrame: 6 months
measure: FEV1
timeFrame: 12 months
measure: Asthma exacerbation severity
timeFrame: Day 1
measure: Asthma exacerbation severity
timeFrame: 12 months
measure: Asthma quality of life questionnaires
timeFrame: Day 1
measure: Asthma quality of life questionnaires
timeFrame: 6 months
measure: Asthma quality of life questionnaires
timeFrame: 12 months
measure: Asthma Control Test questionnaires
timeFrame: day 1
measure: Asthma Control Test questionnaires
timeFrame: 6 months
measure: Asthma Control Test questionnaires
timeFrame: 12 months
measure: Forced Vital Capacity (FVC)
timeFrame: day 1
measure: FVC
timeFrame: 6 months
measure: FVC
timeFrame: 12 months
measure: FEV1/FVC ratio
timeFrame: Day 1
measure: FEV1/FVC ratio
timeFrame: 6 months
measure: FEV1/FVC ratio
timeFrame: 12 months
measure: Forced Expiratory Flow (FEF25-75%)
timeFrame: Day 1
measure: FEF25-75%
timeFrame: 6 months
measure: FEF25-75%
timeFrame: 12 months
measure: PEF
timeFrame: Day 1
measure: PEF
timeFrame: 6 months
measure: PEF
timeFrame: 12 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Patrick Berger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: