Cystic FibrosisNCT04274413
CFTR Related Pancreatitis Study
A study testing Beta Adrenergic Sweat Test in people with Cystic Fibrosis and CFTR Gene Dysfunction, run by The Hospital for Sick Children.
Trial summary
The main causes of acute recurrent pancreatitis (ARP) or chronic pancreatitis (CP) in children are defects in genes that have been associated to pancreatitis. Among these gene defects CFTR gene mutations are commonly found, 34% ARP and 23% CP . Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Cystic Fibrosis, CFTR Gene Dysfunction
- What is being tested?
- Beta Adrenergic Sweat Test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 Feb 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age : 4 years and older
- Diagnosis: Acute recurrent pancreatitis or chronic pancreatitis
- History: at least one of the following:
- Carry one or two CFTR mutations
- Borderline sweat chloride levels
- Has Family History of CF
- Has had positive CF Newborn screening
Who cannot join
- Pregnant females: will be excluded at screening.
About this study
Official title: Assessing CFTR Function in Patients With CFTR Related Pancreatitis Using a Novel Sweat Test
The main causes of acute recurrent pancreatitis (ARP) or chronic pancreatitis (CP) in children are defects in genes that have been associated to pancreatitis. Among these gene defects CFTR gene mutations are commonly found, 34% ARP and 23% CP . Since not every CFTR gene mutations clinically manifest, just identifying these CFTR gene mutations may not help to establish a clear role of this defect in the etiology of the individual ARP/CP. The novel beta-adrenergic sweat secretion test is a very sensitive test to detect small abnormalities in CFTR function in form of a linear gene-function relation. By identifying even mild CFTR defects, in future will help in finding the role of CFTR modulators and providing treatment to these patients.
- Conditions
- Cystic Fibrosis, CFTR Gene Dysfunction
- Being tested
- Beta Adrenergic Sweat Test
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta Adrenergic Sweat TestCombination product
In Beta Sweat Test - sweat secretion will be stimulated by injecting a series of drugs within the skin surface. Small needles will be used to inject minute amounts of each drug. Before and after each skin injection, the skin will be cleaned using an alcohol swab.
- Two sensor probes will be strapped to the forearm with rubber bands in position just above the injection site.
- Under the first probe, injection atropine will be given in one small area of the skin.
- Under the second probe, first injection carbachol will be given in one small area of the skin.
- Next, at the second probe area, the normal sweating will be stopped for awhile by injecting a drug called atropine.
- Lastly, beta-adrenergic sweating will be stimulated by injecting a combination of the following drugs: atropine, isoproterenol, and aminophylline (β-cocktail). Using probes, all sweat rate readings will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | All patients consented to study will undergo study intervention which is Beta-adrenergic sweat test (Beta sweat test) using evaporimeter. It takes about 60 minutes to complete this test. Once this test is completed, patient will be considered to have completed the study. Receives: Combination Product: Beta Adrenergic Sweat Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of CFTR function using the Beta Adrenergic Sweat Secretion Test
CFTR function assessment of patients with acute recurrent or chronic pancreatitis by using Beta adrenergic sweat test.
Measured: 60 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Feb 2021
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it stopped: Due to funding and Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Evaporimeter TEWL probes, model RG-1
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The National Pancreas Foundation
- Responsible party
- Principal investigator, Tanja Gonska, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274413
- Sponsor's protocol ID
- 1000065960
- Status last verified
- Jul 2021
- First submitted
- 16 Feb 2020
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing CFTR Function in Patients With CFTR Related Pancreatitis Using a Novel Sweat Test
- ClinicalTrials.gov ID
- NCT04274413
- Acronym / sponsor ID
- 1000065960
- Conditions
- Cystic Fibrosis, CFTR Gene Dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to funding and Covid-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The National Pancreas Foundation
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 18 Feb 2020 (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 main causes of acute recurrent pancreatitis (ARP) or chronic pancreatitis (CP) in children are defects in genes that have been associated to pancreatitis. Among these gene defects CFTR gene mutations are commonly found, 34% ARP and 23% CP . Since not every CFTR gene mutations clinically manifest, just identifying these CFTR gene mutations may not help to establish a clear role of this defect in the etiology of the individual ARP/CP. The novel beta-adrenergic sweat secretion test is a very sensitive test to detect small abnormalities in CFTR function in form of a linear gene-function relation. By identifying even mild CFTR defects, in future will help in finding the role of CFTR modulators and providing treatment to these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaporimeter TEWL probes, model RG-1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Combination Product: Beta Adrenergic Sweat TestAll patients consented to study will undergo study intervention which is Beta-adrenergic sweat test (Beta sweat test) using evaporimeter. It takes about 60 minutes to complete this test. Once this test is completed, patient will be considered to have completed the study. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age : 4 years and older
- Diagnosis: Acute recurrent pancreatitis or chronic pancreatitis
- History: at least one of the following:
Key exclusion criteria (1 listed)
- Pregnant females: will be excluded at screening.
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 |
|---|---|---|
| Beta Adrenergic Sweat TestIn Beta Sweat Test - sweat secretion will be stimulated by injecting a series of drugs within the skin surface. Small needles will be used to inject minute amounts of each drug. Before and after each skin injection, the skin will be cleaned using an alcohol swab. 1. Two sensor probes will be strapped to the forearm with rubber bands in position just above the injection site. 2. Under the first probe, injection atropine will be given in one small area of the skin. 3. Under the second probe, first injection carbachol will be given in one small area of the skin. 4. Next, at the second probe area, the normal sweating will be stopped for awhile by injecting a drug called atropine. 5. Lastly, beta-adrenergic sweating will be stimulated by injecting a combination of the following drugs: atropine, isoproterenol, and aminophylline (β-cocktail). Using probes, all sweat rate readings will be recorded. | Combination product | Interventional Arm |
Primary outcome
Assessment of CFTR function using the Beta Adrenergic Sweat Secretion Test
Time frame: 60 mins
CFTR function assessment of patients with acute recurrent or chronic pancreatitis by using Beta adrenergic sweat test.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Beta Adrenergic Sweat Test in people with Cystic Fibrosis and CFTR Gene Dysfunction, run by The Hospital for Sick Children.
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 7 inclusion and 1 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: withdrawn, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of CFTR function using the Beta Adrenergic Sweat Secretion Test (time frame: 60 mins). 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 16 Jul 2021; AzTrials last refreshed its copy on 26 Oct 2026.