Evaluation of New Device for Beta-adrenergic Sweat Test in the Context of Stratification of Patient With Cystic Fibrosis

Summary

This is a clinical study to evaluate a new medical system used to perform a sweat secretion-based test for the diagnosis of cystic fibrosis.

This clinical study will involve around 150 individuals in Belgium, including 50 healthy individuals, 50 carriers and 50 patients with cystic fibrosis.

The primary objective is to implement a new system for diagnosing cystic fibrosis according to their response to the beta-adrenergic test.

First session (50 minutes):

1. Left arm: Iontophoresis using the Macroduct for the cholinergic and β-adrenergic stimulation (2 iontophoresis), then bubble test.
2. right arm: Iontophoresis using the Macroduct for the cholinergic and β-adrenergic stimulation (2 iontophoresis), then evaporimetry.

Second session (50 minutes):

1. Left arm: Iontophoresis using the Macroduct for the cholinergic and intradermal injection for the beta-adrenergic stimulation, then bubble test.
2. Right arm: Iontophoresis using the Macroduct for the cholinergic and intradermal injection for the beta-adrenergic stimulation, then evaporimetry.

The secondary objectives of this clinical research are:

* Determining the best mode of administration for beta-adrenergic stimulation
* Assessing the best quantification of sweat secretion
* Comparing the response of the control group and the carrier group
* Evaluating the stratification of people with cystic fibrosis according to CFTR dysfunction

The test consists of 5 steps:

1. sweat stimulation by cholinergic pathway
2. sweat secretion quantification
3. cystic fibrosis specific stimulation: beta-adrenergic pathway
4. sweat secretion quantification
5. analysis Both techniques of sweat stimulation and secretion quantification will be performed and compared to each other. Each participants will therefore have 2 sessions on both arms, with a minimum of one hour between the two sessions.

At each stimulation steps (step 1 to 3), the pain level during the test will be evaluated by self assessment in adults with Visual Analog Scale and children 2 to 6 years old with Faces Pain Scale - Revised or a hetero-assessment of pain for children less than 2 years old with douleur aigue du nouveau-ne scale.

Conditions

• Cystic Fibrosis

Interventions

DEVICE

Sweat stimulation and secretion quantification

First session (50 minutes): a. Left arm: Iontophoresis using the Macroduct for the cholinergic and β-adrenergic stimulation (2 iontophoresis), then bubble test. b. right arm: Iontophoresis using the Macroduct for the cholinergic and β-adrenergic stimulation (2 iontophoresis), then evaporimetry. Second session (50 minutes): a. Left arm: Iontophoresis using the Macroduct for the cholinergic and intradermal injection for the β-adrenergic stimulation, then bubble test. b. Right arm: Iontophoresis using the Macroduct for the cholinergic and intradermal injection for the β-adrenergic stimulation, then evaporimetry.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  lead OTHER

Principal Investigators

• Sophie Gohy · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2029-06-01

Completion

2029-06-01

Countries

• Belgium

Study Locations