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

Asthma Clinical Trial

— AsthmaDom  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990247
• Other study ID #: CHUBX 2015/04
• Status: Completed
• Phase: N/A
• Start date: November 14, 2016
• Est. completion date: November 6, 2018

Study information

• Verified date: December 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 6, 2018
• Est. primary completion date: November 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
France	Grenoble University Hospital	Grenoble
France	Bordeaux University Hospital	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensibility parameters resting breath parameter to predict asthma exacerbation		12 months
Primary	Specificity of resting breath parameters to predict asthma exacerbation		12 months
Primary	Positive predictive value of resting breath parameters to predict asthma exacerbation		12 months
Primary	Negative predictive value of resting breath parameters to predict asthma exacerbation		12 months
Secondary	FEV1	Volume that has been exhaled at the end of the first second of forced expiration	Day 1
Secondary	FEV1	Volume that has been exhaled at the end of the first second of forced expiration	6 months
Secondary	FEV1	Volume that has been exhaled at the end of the first second of forced expiration	12 months
Secondary	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
Secondary	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
Secondary	Asthma quality of life questionnaires		Day 1
Secondary	Asthma quality of life questionnaires		6 months
Secondary	Asthma quality of life questionnaires		12 months
Secondary	Asthma Control Test questionnaires		day 1
Secondary	Asthma Control Test questionnaires		6 months
Secondary	Asthma Control Test questionnaires		12 months
Secondary	Forced Vital Capacity (FVC)	Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort	day 1
Secondary	FVC	Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort	6 months
Secondary	FVC	Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort	12 months
Secondary	FEV1/FVC ratio		Day 1
Secondary	FEV1/FVC ratio		6 months
Secondary	FEV1/FVC ratio		12 months
Secondary	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
Secondary	FEF25-75%	Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled	6 months
Secondary	FEF25-75%	Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled	12 months
Secondary	PEF	Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter	Day 1
Secondary	PEF	Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter	6 months
Secondary	PEF	Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter	12 months