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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Unknown

Conditions: Mucoviscidosis Involving the Lung

Treatments: Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine

Study type: Interventional

Funder types: Other

Identifiers

NCT03584841

2015/04MAI/231

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Patients with mucoviscidosis

Experimental group

Description:

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

Treatment:

Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine

Parents of patients with confirmed diagnosis of mucoviscidosis

Experimental group

Description:

The parents are heterozygous subjects

Treatment:

Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine

Healthy volunteers

Active Comparator group

Treatment:

Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine