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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2021-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Mucoviscidosis Involving the Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Intervention Model: Three Group Assignment

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with mucoviscidosis

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

Group Type EXPERIMENTAL

Iontophoresis sessions in forearm of subjects with pilocarpine

Intervention Type DIAGNOSTIC_TEST

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.

Parents of patients with confirmed diagnosis of mucoviscidosis

The parents are heterozygous subjects

Group Type EXPERIMENTAL

Iontophoresis sessions in forearm of subjects with pilocarpine

Intervention Type DIAGNOSTIC_TEST

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.

Healthy volunteers

Group Type ACTIVE_COMPARATOR

Iontophoresis sessions in forearm of subjects with pilocarpine

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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