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Implementation of a Non-invasive Version of the Imaging β-adrenergic-dependent Sweat Secretion Test

Implementation of a Non-invasive Version of the Imaging β-adrenergic-dependent Sweat Secretion Test: Value for Diagnosis and Efficacy of Target Therapies for Cystic Fibrosis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03584841
Acronym
BUBBLE TEST
Enrollment
120
Registered
2018-07-12
Start date
2017-03-31
Completion date
2021-12-31
Last updated
2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucoviscidosis Involving the Lung

Brief summary

The goal of this study is to implement a non-invasive version of the sweat secretion test based in visualization of sweat glands following β-adrenergic stimulation of sweat. Specifically, the trial will evaluate the relative response of sweat glands to β-adrenergic and cholinergic stimulation among participants with CF, heterozygous and matched control subjects

Interventions

DIAGNOSTIC_TESTIontophoresis sessions in forearm of subjects with pilocarpine

The test with two iontophoresis sessions is performed in a forearm of subjects. Pilocarpine is applied during the first iontophoresis session to evoke cholinergic-induced sweat secretion. Atropine, isoprenaline and aminophylline are applied during the second iontophoresis session, to block the cholinergic component and to evoke β-adrenergic-induced sweat secretion.

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Intervention Model: Three Group Assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* For patients with cystic fibrosis: clinically stable, all genotypes included. * For healthy volunteer and heterozygous subjects: 18 years and older.

Exclusion criteria

* Corticosteroids, anti-leukotriene therapy, unstable clinical status, \<40% FEV1. * Current pregnancy or breastfeeding.

Design outcomes

Primary

MeasureTime frameDescription
Ratio between the β-adrenergic/cholinergic rateup to 30 minutesThe ratio between the β-adrenergic/cholinergic rate (nL/min) of droplets of sweat is calculated.

Countries

Belgium

Contacts

Primary ContactTeresinha LEAL, Biologist
teresinha.leal@uclouvain.be00 32 2 764
Backup ContactAudrey REYNAERTS, Sciences
audrey.reynaerts@uclouvain.be00 32 2 764

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026