Status:

WITHDRAWN

The Comparison of Electronic Auscultation Coupled With CALSA and FRI; Repeatability of FRI Biomarkers

Lead Sponsor:

FLUIDDA nv

Conditions:

Asthma

Eligibility:

All Genders

18-120 years

Phase:

NA

Brief Summary

CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in a group of healthy volunteers and asthma patients.

Detailed Description

his is a study with no investigational product. CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in a group of healthy volunteers and asthma patients. Electr...

Eligibility Criteria

Inclusion

  • Male or female patient / volunteer ≥ 18 years old
  • Written informed consent obtained
  • The subject belongs to 1 of the following groups in the opinion of the investigator:
  • Group 1: healthy volunteer Group 2: patient with asthma
  • Only if patient/ volunteer is a female of childbearing potential: Confirmation that a contraception method was used at least 14 days before visit 1

Exclusion

  • Pregnant or lactating female
  • Patient/ volunteer with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
  • Patient/ volunteer with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.

Key Trial Info

Start Date :

March 1 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2016

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT02228018

Start Date

March 1 2015

End Date

January 1 2016

Last Update

February 3 2016

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Antwerp University Hospital

Edegem, Antwerp, Belgium, 2650