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

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study ID
NCT06836453
Status
Recruiting
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Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Sweat stimulation and secretion quantification — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Feb 20, 2025
Start date
Jan 1, 2025
Status verified
Feb 2025
Primary completion
Jun 1, 2029
Completion
Jun 1, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: EVALUATION OF NEW SYSTEM FOR β-ADRENERGIC SWEAT TEST IN THE CONTEXT OF STRATIFICATION OF PATIENT WI
    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 β-adrenergic stimulation, then bubble test. 2. Right arm: Iontophoresis using the Macroduct for the cholinergic and intradermal injection for the β-adrenergic stimulation, then evaporimetry.

Primary Outcome Measure

Sweat secretion [ Time Frame: 2 hours ]

Central Contacts

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