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

NCT ID: NCT02990247

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-14

Study Completion Date

2018-11-06

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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Asthma Exacerbations Telemonitoring Biomarkers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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AMARS

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

Group Type EXPERIMENTAL

anharmonic morphological analysis of the respiratory signals (AMARS)

Intervention Type DEVICE

Interventions

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anharmonic morphological analysis of the respiratory signals (AMARS)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Berger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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Grenoble University Hospital

Grenoble, , France

Site Status

Bordeaux University Hospital

Pessac, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2015/04

Identifier Type: -

Identifier Source: org_study_id