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

February 19, 2025 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cystic fibrosis (CF) is a rare genetic disease affecting 1 baby in 2,850 live births in Belgium and associated with high morbidity and mortality. CF is caused by CFTR mutations resulting in loss-of-function of the CFTR protein. It leads to dramatic abnormalities in transepithelial ion transport and the production of thick mucus obstructing airways and duct lumens of exocrine glands. The gold standard for CF diagnosis is an accurate Gibson and Cooke sweat test which is very sensitive to lost or abrogated CFTR function, but shows a logarithmic relationship between sweat Cl - content and CFTR function: e.g. a 5% residual CFTR function is associated with sweat Cl- concentrations found below the diagnostic threshold (<60 mmol/L). Consequently, diagnosing CF is challenging in borderline cases and/or in the presence of CFTR mutations not recognized as disease-causing (CFTR2 data base; https://cftr2.org/). Contrary to routine sweat test measuring the CFTR-mediated reabsorption of Cl- in the sweat duct, beta-adrenergic sweat secretion test (BAST) measures CFTR mediated secretion of Cl- in the secretory coil of the sweat gland . Sato and Sato discovered in the early 1980s that CFTR-mediated sweat secretion can be stimulated with β-adrenergic agonists if the thermoregulative cholinergic sweat secretion is simultaneously inhibited with atropine . β-adrenergic sweat secretion was absent in people with CF (pwCF) and half-maximal in healthy heterozygous carriers of CFTR mutation (HTZ). Therefore, BAST seems to be a highly sensitive CFTR bioassay suitable for screening of CFTR dysfunction, monitoring the efficacy of new therapeutic interventions and differential diagnosis of exocrine pancreatic sufficient-CF, CFTR-Related disease and cystic fibrosis screen positive and finallyinconclusive diagnosis. BAST detect the relative improvement due to a novel treatment, while at the same time show that the levels did not return to a normal range. The available measurement range can thus be used to assess the individual response to therapeutic interventions, but can also be used to stratify patients in the intermediate range of activity, which fall into a spectrum, ranging from a severe loss of function in classical cystic fibrosis to the cystic fibrosis related disease with a relatively lowered activity.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
          • Sophie Gohy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sweat secretion
Time Frame: 2 hours

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment score
Time Frame: 2 hours
Pain during the test will be assessed by self-report in adults and children >6 years old, or by hetero-report in children <6 years old. A score > 3-4/10 leads to discontinuation of the test.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Sophie Gohy, Cliniques Universitaires Saint-Luc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIV-24-02-046176

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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