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AsthmaAsthmaDomNCT02990247

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

A study testing anharmonic morphological analysis of the respiratory signals (AMARS) in people with Asthma, run by University Hospital, Bordeaux at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
anharmonic morphological analysis of the respiratory signals (AMARS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesFrance
Study dates
14 Nov 2016to 6 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • smoker or former smoker (> 10 packs-year)
  • concomitant asthma exacerbation (at V1)
  • prisoners
  • protected adults
  • no affiliation to the French Social Security System

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Grenoble University Hospital

    Grenoble, 38043

  • Bordeaux University Hospital

    Pessac, 33600

Other trials in France

About this study

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.

Read the 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.

Conditions
Asthma
Being tested
anharmonic morphological analysis of the respiratory signals (AMARS)
Keywords
Asthma, Exacerbations, Telemonitoring, Biomarkers
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anharmonic morphological analysis of the respiratory signals (AMARS)Device

Study groups in NCT02990247
Study groupRoleWhat they receive
AMARSExperimentalEvaluation the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS).
Receives: Device: anharmonic morphological analysis of the respiratory signals (AMARS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensibility parameters resting breath parameter to predict asthma exacerbation

    Measured: 12 months

  2. Specificity of resting breath parameters to predict asthma exacerbation

    Measured: 12 months

  3. Positive predictive value of resting breath parameters to predict asthma exacerbation

    Measured: 12 months

  4. Negative predictive value of resting breath parameters to predict asthma exacerbation

    Measured: 12 months

Secondary outcomes (23)

  1. FEV1

    Volume that has been exhaled at the end of the first second of forced expiration

    Measured: Day 1

  2. FEV1

    Volume that has been exhaled at the end of the first second of forced expiration

    Measured: 6 months

  3. FEV1

    Volume that has been exhaled at the end of the first second of forced expiration

    Measured: 12 months

  4. 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).

    Measured: Day 1

  5. 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).

    Measured: 12 months

  6. Asthma quality of life questionnaires

    Measured: Day 1

  7. Asthma quality of life questionnaires

    Measured: 6 months

  8. Asthma quality of life questionnaires

    Measured: 12 months

  9. Asthma Control Test questionnaires

    Measured: day 1

  10. Asthma Control Test questionnaires

    Measured: 6 months

  11. Asthma Control Test questionnaires

    Measured: 12 months

  12. Forced Vital Capacity (FVC)

    Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort

    Measured: day 1

  13. FVC

    Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort

    Measured: 6 months

  14. FVC

    Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort

    Measured: 12 months

  15. FEV1/FVC ratio

    Measured: Day 1

  16. FEV1/FVC ratio

    Measured: 6 months

  17. FEV1/FVC ratio

    Measured: 12 months

  18. Forced Expiratory Flow (FEF25-75%)

    Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled

    Measured: Day 1

  19. FEF25-75%

    Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled

    Measured: 6 months

  20. FEF25-75%

    Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled

    Measured: 12 months

  21. PEF

    Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter

    Measured: Day 1

  22. PEF

    Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter

    Measured: 6 months

  23. PEF

    Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2016 (estimated)
  2. Study start14 Nov 2016
  3. Primary completion6 Nov 2018
  4. Study completion6 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02990247
Sponsor's protocol ID
CHUBX 2015/04
Other IDs
2016-A01116-45
Acronym
AsthmaDom
Status last verified
Dec 2018
First submitted
2 Dec 2016
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing anharmonic morphological analysis of the respiratory signals (AMARS) in people with Asthma, run by University Hospital, Bordeaux at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensibility parameters resting breath parameter to predict asthma exacerbation (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02990247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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