Cystic FibrosisBESTRACYFICNCT06836453
Evaluation of New Device for Beta-adrenergic Sweat Test in the Context of Stratification of Patient With Cystic Fibrosis
A study testing Sweat stimulation and secretion quantification in people with Cystic Fibrosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Sweat stimulation and secretion quantification
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2025to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy volunteers
- carriers (e.g. parents of people with cystic fibrosis)
- people with known cystic fibrosis or classified as cystic fibrosis related disease
Who cannot join
- Any individual with skin lesions affecting the measurement site
- pregnant or breastfeeding women
- participants with temporary or definitive disabilities to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Angélique Mottais contact
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Sophie Gohy
About this study
Official title: 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.
Read more
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):
- Left arm: Iontophoresis using the Macroduct for the cholinergic and β-adrenergic stimulation (2 iontophoresis), then bubble test.
- right arm: Iontophoresis using the Macroduct for the cholinergic and β-adrenergic stimulation (2 iontophoresis), then evaporimetry.
Second session (50 minutes):
- Left arm: Iontophoresis using the Macroduct for the cholinergic and intradermal injection for the beta-adrenergic stimulation, then bubble test.
- 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:
- 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.
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Sweat stimulation and secretion quantification
- Keywords
- Cystic fibrosis, Beta-adrenergic sweat test, Stratification
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sweat stimulation and secretion quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (1)
Pain assessment score
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jan 2025
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Gohy, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836453
- Sponsor's protocol ID
- CIV-24-02-046176
- Acronym
- BESTRACYFIC
- Status last verified
- Feb 2025
- First submitted
- 6 Jan 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34756683Zampoli 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.
PubMed 36193559Reynaerts 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.
PubMed 34489187
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New System for β-adrenergic Sweat Test in the Context of Stratification of Patient With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06836453
- Acronym / sponsor ID
- BESTRACYFIC / CIV-24-02-046176
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Beta-adrenergic sweat test, Stratification
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Left arm: Iontophoresis using the Macroduct for the cholinergic and β-adrenergic stimulation (2 iontophoresis), then bubble test.
- right arm: Iontophoresis using the Macroduct for the cholinergic and β-adrenergic stimulation (2 iontophoresis), then evaporimetry.
Second session (50 minutes):
- Left arm: Iontophoresis using the Macroduct for the cholinergic and intradermal injection for the beta-adrenergic stimulation, then bubble test.
- 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:
- 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVALUATION OF NEW SYSTEM FOR β-ADRENERGIC SWEAT TEST IN THE CONTEXT OF STRATIFICATION OF PATIENT WI | Experimental | Device: Sweat stimulation and secretion quantificationFirst 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- carriers (e.g. parents of people with cystic fibrosis)
- people with known cystic fibrosis or classified as cystic fibrosis related disease
Key exclusion criteria (3 listed)
- Any individual with skin lesions affecting the measurement site
- pregnant or breastfeeding women
- participants with temporary or definitive disabilities to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sweat stimulation and secretion quantificationFirst 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. | Device | EVALUATION OF NEW SYSTEM FOR β-ADRENERGIC SWEAT TEST IN THE CONTEXT OF STRATIFICATION OF PATIENT WI |
Primary outcome
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.
1 secondary outcome
Pain assessment score
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Background: PubMed 34756683Pallenberg 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.
- Background: PubMed 36193559Zampoli 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.
- Background: PubMed 34489187Reynaerts 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angélique Mottais contact
Sophie Gohy principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sweat stimulation and secretion quantification in people with Cystic Fibrosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Gohy, MD,PhD (+32 2 764 80 64, sophie.gohy@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sweat secretion (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06836453, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.