NCT06836453

Brief 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):

  • 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:
  • sweat stimulation by cholinergic pathway
  • sweat secretion quantification
  • cystic fibrosis specific stimulation: beta-adrenergic pathway
  • sweat secretion quantification
  • 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress31%
Jan 2025Jun 2029

Study Start

First participant enrolled

January 1, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

4.4 years

First QC Date

January 6, 2025

Last Update Submit

February 19, 2025

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosisBeta-adrenergic sweat testStratification

Outcome Measures

Primary Outcomes (1)

  • Sweat secretion

    To distinguish people with cystic fibrosis, the beta-adrenergic sweat rate less than or equal to 4.5 TEWL and the beta-adrenergic:cholinergic ratio less than or equal to 0.05 measured by the evaporimetry test will be used. For the bubble test, a β-adrenergic sweat rate of less than 0.16 nL/min will be used to define a CF base range.

    2 hours

Secondary Outcomes (1)

  • Pain assessment score

    2 hours

Study Arms (1)

EVALUATION OF NEW SYSTEM FOR β-ADRENERGIC SWEAT TEST IN THE CONTEXT OF STRATIFICATION OF PATIENT WI

EXPERIMENTAL

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.

Device: Sweat stimulation and secretion quantification

Interventions

Sweat stimulation and secretion quantificationDEVICE

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.

EVALUATION OF NEW SYSTEM FOR β-ADRENERGIC SWEAT TEST IN THE CONTEXT OF STRATIFICATION OF PATIENT WI

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (3)

  • Pallenberg ST, Junge S, Ringshausen FC, Sauer-Heilborn A, Hansen G, Dittrich AM, Tummler B, Nietert M. CFTR modulation with elexacaftor-tezacaftor-ivacaftor in people with cystic fibrosis assessed by the beta-adrenergic sweat rate assay. J Cyst Fibros. 2022 May;21(3):442-447. doi: 10.1016/j.jcf.2021.10.005. Epub 2021 Oct 29.

    PMID: 34756683BACKGROUND

  • Zampoli M, Verstraete J, Nguyen-Khoa T, Sermet-Gaudelus I, Zar HJ, Gonska T, Morrow BM. beta-adrenergic sweat test in children with inconclusive cystic fibrosis diagnosis: Do we need new reference ranges? Pediatr Pulmonol. 2023 Jan;58(1):187-196. doi: 10.1002/ppul.26179. Epub 2022 Oct 17.

    PMID: 36193559BACKGROUND

  • Reynaerts A, Vermeulen F, Mottais A, Gohy S, Lebecque P, Frederick R, Vanbever R, Leal T. Needle-free iontophoresis-driven beta-adrenergic sweat rate test. J Cyst Fibros. 2022 May;21(3):407-415. doi: 10.1016/j.jcf.2021.08.012. Epub 2021 Sep 4.

    PMID: 34489187BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Sophie Gohy

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Gohy, MD,PhD

CONTACT

+32 2 764 80 64sophie.gohy@uclouvain.be

Angélique Mottais

CONTACT

angelique.mottais@uclouvain.be

Study Design

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

Study Record Dates

First Submitted

January 6, 2025

First Posted

February 20, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

February 20, 2025

Record last verified: 2025-02

Locations

BE(1)