Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study (AsthmaDom)
19. maj 2026 opdateret af: University Hospital, Bordeaux
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
120
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Grenoble, Frankrig, 38043
- Grenoble University Hospital
-
Pessac, Frankrig, 33600
- Bordeaux University Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: AMARS
Evaluation the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Sensibility parameters resting breath parameter to predict asthma exacerbation
Tidsramme: 12 months
|
12 months
|
|
Specificity of resting breath parameters to predict asthma exacerbation
Tidsramme: 12 months
|
12 months
|
|
Positive predictive value of resting breath parameters to predict asthma exacerbation
Tidsramme: 12 months
|
12 months
|
|
Negative predictive value of resting breath parameters to predict asthma exacerbation
Tidsramme: 12 months
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
FEV1
Tidsramme: Day 1
|
Volume that has been exhaled at the end of the first second of forced expiration
|
Day 1
|
|
FEV1
Tidsramme: 6 months
|
Volume that has been exhaled at the end of the first second of forced expiration
|
6 months
|
|
FEV1
Tidsramme: 12 months
|
Volume that has been exhaled at the end of the first second of forced expiration
|
12 months
|
|
Asthma exacerbation severity
Tidsramme: Day 1
|
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
Tidsramme: 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).
|
12 months
|
|
Asthma quality of life questionnaires
Tidsramme: Day 1
|
Day 1
|
|
|
Asthma quality of life questionnaires
Tidsramme: 6 months
|
6 months
|
|
|
Asthma quality of life questionnaires
Tidsramme: 12 months
|
12 months
|
|
|
Asthma Control Test questionnaires
Tidsramme: day 1
|
day 1
|
|
|
Asthma Control Test questionnaires
Tidsramme: 6 months
|
6 months
|
|
|
Asthma Control Test questionnaires
Tidsramme: 12 months
|
12 months
|
|
|
Forced Vital Capacity (FVC)
Tidsramme: day 1
|
Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
|
day 1
|
|
FVC
Tidsramme: 6 months
|
Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
|
6 months
|
|
FVC
Tidsramme: 12 months
|
Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
|
12 months
|
|
FEV1/FVC ratio
Tidsramme: Day 1
|
Day 1
|
|
|
FEV1/FVC ratio
Tidsramme: 6 months
|
6 months
|
|
|
FEV1/FVC ratio
Tidsramme: 12 months
|
12 months
|
|
|
Forced Expiratory Flow (FEF25-75%)
Tidsramme: Day 1
|
Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled
|
Day 1
|
|
FEF25-75%
Tidsramme: 6 months
|
Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled
|
6 months
|
|
FEF25-75%
Tidsramme: 12 months
|
Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled
|
12 months
|
|
PEF
Tidsramme: Day 1
|
Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter
|
Day 1
|
|
PEF
Tidsramme: 6 months
|
Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter
|
6 months
|
|
PEF
Tidsramme: 12 months
|
Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter
|
12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Patrick BERGER, MD, PhD, University Hospital, Bordeaux
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. november 2016
Primær færdiggørelse (Faktiske)
6. november 2018
Studieafslutning (Faktiske)
6. november 2018
Datoer for studieregistrering
Først indsendt
2. december 2016
Først indsendt, der opfyldte QC-kriterier
8. december 2016
Først opslået (Anslået)
13. december 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2026
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CHUBX 2015/04
- 2016-A01116-45 (Anden identifikator: ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .