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

Mucoviscidosis Involving the Lung Clinical Trial

— BUBBLE TEST  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03584841
• Other study ID #: 2015/04MAI/231
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Teresinha LEAL, Biologist
• Phone: 00 32 2 764
• Email: teresinha.leal[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Mucoviscidosis Involving the Lung

Intervention

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 ß-adrenergic-induced sweat secretion.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio between the ß-adrenergic/cholinergic rate	The ratio between the ß-adrenergic/cholinergic rate (nL/min) of droplets of sweat is calculated.	up to 30 minutes