Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study (AsthmaDom)
11 december 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
120
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Grenoble, Frankrike, 38043
- Grenoble University Hospital
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Pessac, Frankrike, 33600
- Bordeaux University Hospital
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: AMARS
Evaluation the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Sensibility parameters resting breath parameter to predict asthma exacerbation
Tidsram: 12 months
|
12 months
|
|
Specificity of resting breath parameters to predict asthma exacerbation
Tidsram: 12 months
|
12 months
|
|
Positive predictive value of resting breath parameters to predict asthma exacerbation
Tidsram: 12 months
|
12 months
|
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Negative predictive value of resting breath parameters to predict asthma exacerbation
Tidsram: 12 months
|
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
FEV1
Tidsram: Day 1
|
Volume that has been exhaled at the end of the first second of forced expiration
|
Day 1
|
|
FEV1
Tidsram: 6 months
|
Volume that has been exhaled at the end of the first second of forced expiration
|
6 months
|
|
FEV1
Tidsram: 12 months
|
Volume that has been exhaled at the end of the first second of forced expiration
|
12 months
|
|
Asthma exacerbation severity
Tidsram: 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
Tidsram: 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
Tidsram: Day 1
|
Day 1
|
|
|
Asthma quality of life questionnaires
Tidsram: 6 months
|
6 months
|
|
|
Asthma quality of life questionnaires
Tidsram: 12 months
|
12 months
|
|
|
Asthma Control Test questionnaires
Tidsram: day 1
|
day 1
|
|
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Asthma Control Test questionnaires
Tidsram: 6 months
|
6 months
|
|
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Asthma Control Test questionnaires
Tidsram: 12 months
|
12 months
|
|
|
Forced Vital Capacity (FVC)
Tidsram: day 1
|
Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
|
day 1
|
|
FVC
Tidsram: 6 months
|
Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
|
6 months
|
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FVC
Tidsram: 12 months
|
Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
|
12 months
|
|
FEV1/FVC ratio
Tidsram: Day 1
|
Day 1
|
|
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FEV1/FVC ratio
Tidsram: 6 months
|
6 months
|
|
|
FEV1/FVC ratio
Tidsram: 12 months
|
12 months
|
|
|
Forced Expiratory Flow (FEF25-75%)
Tidsram: 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%
Tidsram: 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%
Tidsram: 12 months
|
Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled
|
12 months
|
|
PEF
Tidsram: Day 1
|
Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter
|
Day 1
|
|
PEF
Tidsram: 6 months
|
Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter
|
6 months
|
|
PEF
Tidsram: 12 months
|
Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter
|
12 months
|
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
14 november 2016
Primärt slutförande (Faktisk)
6 november 2018
Avslutad studie (Faktisk)
6 november 2018
Studieregistreringsdatum
Först inskickad
2 december 2016
Först inskickad som uppfyllde QC-kriterierna
8 december 2016
Första postat (Uppskatta)
13 december 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 december 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 december 2018
Senast verifierad
1 december 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CHUBX 2015/04
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