NCT02990247

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2018

Completed
Last Updated

May 20, 2026

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

December 2, 2016

Last Update Submit

May 19, 2026

Conditions

Asthma

Keywords

AsthmaExacerbationsTelemonitoringBiomarkers

Outcome Measures

Primary Outcomes (4)

  • Sensibility parameters resting breath parameter to predict asthma exacerbation

    12 months

  • Specificity of resting breath parameters to predict asthma exacerbation

    12 months

  • Positive predictive value of resting breath parameters to predict asthma exacerbation

    12 months

  • Negative predictive value of resting breath parameters to predict asthma exacerbation

    12 months

Secondary Outcomes (23)

  • FEV1

    Day 1

  • FEV1

    6 months

  • FEV1

    12 months

  • Asthma exacerbation severity

    Day 1

  • Asthma exacerbation severity

    12 months

  • +18 more secondary outcomes

Study Arms (1)

AMARS

EXPERIMENTAL

Evaluation the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS).

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

Interventions

anharmonic morphological analysis of the respiratory signals (AMARS)DEVICE
AMARS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Grenoble University Hospital

Grenoble, 38043, France

Location

Bordeaux University Hospital

Pessac, 33600, France

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Patrick Berger, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 13, 2016

Study Start

November 14, 2016

Primary Completion

November 6, 2018

Study Completion

November 6, 2018

Last Updated

May 20, 2026

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)