|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 April 2021 |
|
Main ID: |
NCT03584841 |
|
Date of registration:
|
27/05/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Implementation of a Non-invasive Version of the Imaging ß-adrenergic-dependent Sweat Secretion Test
BUBBLE TEST |
|
Scientific title:
|
Implementation of a Non-invasive Version of the Imaging ß-adrenergic-dependent Sweat Secretion Test: Value for Diagnosis and Efficacy of Target Therapies for Cystic Fibrosis |
|
Date of first enrolment:
|
March 31, 2017 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03584841 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
Teresinha LEAL, Biologist |
|
Address:
|
|
|
Telephone:
|
00 32 2 764 |
|
Email:
|
teresinha.leal@uclouvain.be |
|
Affiliation:
|
|
|
|
Name:
|
Teresinha LEAL, Biologist |
|
Address:
|
|
|
Telephone:
|
00 32 2 764 |
|
Email:
|
teresinha.leal@uclouvain.be |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
100 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Mucoviscidosis Involving the Lung
|
|
Intervention(s)
|
|
Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine
|
|
Primary Outcome(s)
|
|
Ratio between the ß-adrenergic/cholinergic rate
[Time Frame: up to 30 minutes]
|
|
Secondary ID(s)
|
|
2015/04MAI/231
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|