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

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

Study Overview

• Status: Recruiting
• Conditions: Mucoviscidosis Involving the Lung
• Intervention / Treatment: Diagnostic test: Iontophoresis sessions in forearm of subjects with pilocarpine

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Teresinha LEAL, Biologist; Phone Number: 94 73 00 32 2 764; Email: teresinha.leal@uclouvain.be
• Study Contact Backup: Name: Audrey REYNAERTS, Sciences; Phone Number: 94 72 00 32 2 764; Email: audrey.reynaerts@uclouvain.be

Study Locations

• Belgium
  • Brussel, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: Teresinha LEAL, Biologist; Phone Number: 9473 00 32 2 764; Email: teresinha.leal@uclouvain.be
    • Contact: Audrey REYNAERTS; Phone Number: 9472 00 32 2 764; Email: audrey.reynaerts@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2017
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 27, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Miotics; Muscarinic Agonists; Pilocarpine
• Other Study ID Numbers: 2015/04MAI/231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: There is no plan now

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No