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Completed

NCT Number: NCT02990247

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble University Hospital, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anharmonic morphological analysis of the respiratory signals (AMARS)

Device

Primary outcomes

  1. Sensibility parameters resting breath parameter to predict asthma exacerbation

    Time frame: 12 months

  2. Specificity of resting breath parameters to predict asthma exacerbation

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

Secondary outcomes

  1. FEV1

    Time frame: Day 1

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

  2. FEV1

    Time frame: 6 months

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

  3. FEV1

    Time frame: 12 months

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

  4. Asthma exacerbation severity

    Time frame: 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).

  5. Asthma exacerbation severity

    Time frame: 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).

  6. Asthma quality of life questionnaires

    Time frame: Day 1

  7. Asthma quality of life questionnaires

    Time frame: 6 months

  8. Asthma quality of life questionnaires

    Time frame: 12 months

  9. Asthma Control Test questionnaires

    Time frame: day 1

  10. Asthma Control Test questionnaires

    Time frame: 6 months

  11. Asthma Control Test questionnaires

    Time frame: 12 months

  12. Forced Vital Capacity (FVC)

    Time frame: day 1

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

  13. FVC

    Time frame: 6 months

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

  14. FVC

    Time frame: 12 months

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

  15. FEV1/FVC ratio

    Time frame: Day 1

  16. FEV1/FVC ratio

    Time frame: 6 months

  17. FEV1/FVC ratio

    Time frame: 12 months

  18. Forced Expiratory Flow (FEF25-75%)

    Time frame: Day 1

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

  19. FEF25-75%

    Time frame: 6 months

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

  20. FEF25-75%

    Time frame: 12 months

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

  21. PEF

    Time frame: Day 1

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

  22. PEF

    Time frame: 6 months

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

  23. PEF

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: AsthmaDom

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2016
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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