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

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ClinicalTrials.gov Identifier: NCT03584841
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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

Condition or disease Intervention/treatment Phase
Mucoviscidosis Involving the Lung Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention Model: Three Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Ratio between the β-adrenergic/cholinergic rate [ Time Frame: up to 30 minutes ]
    The ratio between the β-adrenergic/cholinergic rate (nL/min) of droplets of sweat is calculated.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584841


Contacts
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Contact: Teresinha LEAL, Biologist 00 32 2 764 ext 94 73 teresinha.leal@uclouvain.be
Contact: Audrey REYNAERTS, Sciences 00 32 2 764 ext 94 72 audrey.reynaerts@uclouvain.be

Locations
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Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussel, Belgium, 1200
Contact: Teresinha LEAL, Biologist    00 32 2 764 ext 9473    teresinha.leal@uclouvain.be   
Contact: Audrey REYNAERTS    00 32 2 764 ext 9472    audrey.reynaerts@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03584841     History of Changes
Other Study ID Numbers: 2015/04MAI/231
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There is no plan now

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Adrenergic Agents
Pilocarpine
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents