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

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Recruiting
CT.gov ID
NCT03584841
Collaborator
(none)
120
1
3
57
2.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Intervention Model: Three Group AssignmentIntervention Model: Three Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
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
Actual Study Start Date :
Mar 31, 2017
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with mucoviscidosis

For patients with cystic fibrosis: clinically stable, all genotypes included.

Diagnostic Test: Iontophoresis 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.

Experimental: Parents of patients with confirmed diagnosis of mucoviscidosis

The parents are heterozygous subjects

Diagnostic Test: Iontophoresis 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.

Active Comparator: Healthy volunteers

Diagnostic Test: Iontophoresis 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.

Outcome Measures

Primary Outcome Measures

  1. Ratio between the β-adrenergic/cholinergic rate [up to 30 minutes]

    The ratio between the β-adrenergic/cholinergic rate (nL/min) of droplets of sweat is calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cliniques universitaires Saint-Luc Brussel Belgium 1200

Sponsors and Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT03584841
Other Study ID Numbers:
  • 2015/04MAI/231
First Posted:
Jul 12, 2018
Last Update Posted:
Mar 24, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2021