Back to resultsImplementation of a Non-invasive Version of the Imaging β-adrenergic-dependent Sweat Secretion Test (BUBBLE TEST)
Primary Purpose
Mucoviscidosis Involving the Lung
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Iontophoresis sessions in forearm of subjects with pilocarpine
Sponsored by
About this trial
This is an interventional diagnostic trial for Mucoviscidosis Involving the Lung
Eligibility 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.
Sites / Locations
- Cliniques universitaires Saint-LucRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Patients with mucoviscidosis
Parents of patients with confirmed diagnosis of mucoviscidosis
Healthy volunteers
Arm Description
For patients with cystic fibrosis: clinically stable, all genotypes included.
The parents are heterozygous subjects
Outcomes
Primary Outcome Measures
Ratio between the β-adrenergic/cholinergic rate
The ratio between the β-adrenergic/cholinergic rate (nL/min) of droplets of sweat is calculated.
Secondary Outcome Measures
Full Information
NCT ID
NCT03584841
First Posted
May 27, 2018
Last Updated
March 23, 2021
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03584841
Brief Title
Implementation of a Non-invasive Version of the Imaging β-adrenergic-dependent Sweat Secretion Test
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucoviscidosis Involving the Lung
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention Model: Three Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with mucoviscidosis
Arm Type
Experimental
Arm Description
For patients with cystic fibrosis: clinically stable, all genotypes included.
Arm Title
Parents of patients with confirmed diagnosis of mucoviscidosis
Arm Type
Experimental
Arm Description
The parents are heterozygous subjects
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Iontophoresis sessions in forearm of subjects with pilocarpine
Intervention Description
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 Measure Information:
Title
Ratio between the β-adrenergic/cholinergic rate
Description
The ratio between the β-adrenergic/cholinergic rate (nL/min) of droplets of sweat is calculated.
Time Frame
up to 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresinha LEAL, Biologist
Phone
00 32 2 764
Ext
94 73
Email
teresinha.leal@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey REYNAERTS, Sciences
Phone
00 32 2 764
Ext
94 72
Email
audrey.reynaerts@uclouvain.be
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresinha LEAL, Biologist
Phone
00 32 2 764
Ext
9473
Email
teresinha.leal@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Audrey REYNAERTS
Phone
00 32 2 764
Ext
9472
Email
audrey.reynaerts@uclouvain.be
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is no plan now
Learn more about this trial
Implementation of a Non-invasive Version of the Imaging β-adrenergic-dependent Sweat Secretion Test
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