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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: anharmonic morphological analysis of the respiratory signals (AMARS)

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Grenoble University Hospital
  • Pessac, France, 33600
    • Bordeaux University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMARS; Evaluation the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS).	Device: anharmonic morphological analysis of the respiratory signals (AMARS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensibility parameters resting breath parameter to predict asthma exacerbation	12 months
Specificity of resting breath parameters to predict asthma exacerbation	12 months
Positive predictive value of resting breath parameters to predict asthma exacerbation	12 months
Negative predictive value of resting breath parameters to predict asthma exacerbation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1	Volume that has been exhaled at the end of the first second of forced expiration	Day 1
FEV1	Volume that has been exhaled at the end of the first second of forced expiration	6 months
FEV1	Volume that has been exhaled at the end of the first second of forced expiration	12 months
Asthma exacerbation severity	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).	Day 1
Asthma exacerbation severity	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).	12 months
Asthma quality of life questionnaires		Day 1
Asthma quality of life questionnaires		6 months
Asthma quality of life questionnaires		12 months
Asthma Control Test questionnaires		day 1
Asthma Control Test questionnaires		6 months
Asthma Control Test questionnaires		12 months
Forced Vital Capacity (FVC)	Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort	day 1
FVC	Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort	6 months
FVC	Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort	12 months
FEV1/FVC ratio		Day 1
FEV1/FVC ratio		6 months
FEV1/FVC ratio		12 months
Forced Expiratory Flow (FEF25-75%)	Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled	Day 1
FEF25-75%	Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled	6 months
FEF25-75%	Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled	12 months
PEF	Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter	Day 1
PEF	Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter	6 months
PEF	Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Patrick BERGER, MD, PhD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2016
• Primary Completion (Actual): November 6, 2018
• Study Completion (Actual): November 6, 2018

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimated): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Asthma; Telemonitoring; Biomarkers; Exacerbations
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: CHUBX 2015/04; 2016-A01116-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO