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

Recruiting now · Not applicable

Conditions studied: Cystic Fibrosis

In brief

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 facts

Study ID

NCT06836453

Run by

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

People needed

150

Starts

2025-01-01

Expected to finish

2029-06-01

Last updated by the study team

2025-02-20

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy volunteers
• carriers (e.g. parents of people with cystic fibrosis)
• people with known cystic fibrosis or classified as cystic fibrosis related disease

You may not qualify if…

• Any individual with skin lesions affecting the measurement site
• pregnant or breastfeeding women
• participants with temporary or definitive disabilities to give consent

Where it is running

• Cliniques Universitaires Saint-Luc — Brussels, Belgium (enrolling)

Full record on ClinicalTrials.gov

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