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

Not Applicable

• Conditions: Mucoviscidosis Involving the Lung
• Interventions: Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine

• Registration Number: NCT03584841
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-31
• Study First Submitted: 2018-05-27
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-24
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with mucoviscidosis	Iontophoresis sessions in forearm of subjects with pilocarpine	For patients with cystic fibrosis: clinically stable, all genotypes included.
Parents of patients with confirmed diagnosis of mucoviscidosis	Iontophoresis sessions in forearm of subjects with pilocarpine	The parents are heterozygous subjects
Healthy volunteers	Iontophoresis sessions in forearm of subjects with pilocarpine	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussel, Belgium