Mucoviscidosis Involving the LungBUBBLE TESTNCT03584841
Implementation of a Non-invasive Version of the Imaging β-adrenergic-dependent Sweat Secretion Test
A study testing Iontophoresis sessions in forearm of subjects with pilocarpine in people with Mucoviscidosis Involving the Lung, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucoviscidosis Involving the Lung
- What is being tested?
- Iontophoresis sessions in forearm of subjects with pilocarpine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Mar 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patients with cystic fibrosis: clinically stable, all genotypes included.
- For healthy volunteer and heterozygous subjects: 18 years and older.
Who cannot join
- Corticosteroids, anti-leukotriene therapy, unstable clinical status, <40% FEV1.
- Current pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Teresinha LEAL, Biologist, 00 32 2 764 ext. 9473, teresinha.leal@uclouvain.be
Audrey REYNAERTS, 00 32 2 764 ext. 9472, audrey.reynaerts@uclouvain.be
About this study
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
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
- Conditions
- Mucoviscidosis Involving the Lung
- Being tested
- Iontophoresis sessions in forearm of subjects with pilocarpine
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iontophoresis sessions in forearm of subjects with pilocarpineDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with mucoviscidosis | Experimental | For patients with cystic fibrosis: clinically stable, all genotypes included. Receives: Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine |
| Parents of patients with confirmed diagnosis of mucoviscidosis | Experimental | The parents are heterozygous subjects Receives: Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine |
| Healthy volunteers | Active comparator | Not described Receives: Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio between the β-adrenergic/cholinergic rate
The ratio between the β-adrenergic/cholinergic rate (nL/min) of droplets of sweat is calculated.
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start31 Mar 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucoviscidosis Involving the LungStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Model: Three Group Assignment
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584841
- Sponsor's protocol ID
- 2015/04MAI/231
- Acronym
- BUBBLE TEST
- Status last verified
- Mar 2021
- First submitted
- 27 May 2018
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no plan now
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03584841
- Acronym / sponsor ID
- BUBBLE TEST / 2015/04MAI/231
- Conditions
- Mucoviscidosis Involving the Lung
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Intervention Model: Three Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Patients with mucoviscidosis | Experimental | Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpineFor patients with cystic fibrosis: clinically stable, all genotypes included. |
| Parents of patients with confirmed diagnosis of mucoviscidosis | Experimental | Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpineThe parents are heterozygous subjects |
| Healthy volunteers | Active comparator | Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For patients with cystic fibrosis: clinically stable, all genotypes included.
- For healthy volunteer and heterozygous subjects: 18 years and older.
Key exclusion criteria (2 listed)
- Corticosteroids, anti-leukotriene therapy, unstable clinical status, <40% FEV1.
- Current pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iontophoresis sessions in forearm of subjects with pilocarpineThe 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. | Diagnostic test | Healthy volunteers, Parents of patients with confirmed diagnosis of mucoviscidosis, Patients with mucoviscidosis |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: Undecided. There is no plan now
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iontophoresis sessions in forearm of subjects with pilocarpine in people with Mucoviscidosis Involving the Lung, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresinha LEAL, Biologist (00 32 2 764 ext. 94 73, teresinha.leal@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio between the β-adrenergic/cholinergic rate (time frame: up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.