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

Study Overview
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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

Official Title
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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

Conditions
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Mucoviscidosis Involving the Lung

Intervention / Treatment
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* Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine


Participation Criteria
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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. Exclusion Criteria: Corticosteroids, anti-leukotriene therapy, unstable clinical status, <40% FEV1. Current pregnancy or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention Model: Three Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with mucoviscidosis<br>For patients with cystic fibrosis: clinically stable, all genotypes included. | Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine<br>* 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.<br>|
| Experimental: Parents of patients with confirmed diagnosis of mucoviscidosis<br>The parents are heterozygous subjects | Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine<br>* 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.<br>|
| Active Comparator: Healthy volunteers<br> | Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio between the β-adrenergic/cholinergic rate | The ratio between the β-adrenergic/cholinergic rate (nL/min) of droplets of sweat is calculated. | up to 30 minutes |