Cystic FibrosisSweat-CFNCT05896488
Sweat Response, Sweat Composition and Thermoregulatory Response to Exercise in Heat in Adults With Cystic Fibrosis on Modulator Therapy.
An observational study of Cystic Fibrosis, run by University of Portsmouth at 1 site in United Kingdom.
Trial summary
Cystic fibrosis (CF) is a common inherited condition in the Caucasian population resulting in poor function and/or production of the CF transmembrane conductance regulator (CFTR) protein. The CFTR protein plays a crucial role in the secretion and re-absorption of sodium chloride within the sweat gland. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Mar 2023to 18 Mar 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Participants will be recruited from adult CF outpatient clinics within the CF network. If a potential participant outside of the CF network wishes to participant they will be screened by the CF consultants within the CF network.
Who may be able to join
- Is taking CFTRm
- Males and females ≥ 18 years of age
- CF diagnosis based on clinical features, supported by a history of an abnormal sweat test (sweat [Cl-] > 60 mmol·L-1 > 100 mg sweat), where possible, diagnostic genotyping would also be desired
- Can clearly state that they are not pregnant
- No contraindications to performing exhaustive exercise
- Can understand and cooperate with the study protocol
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- No exacerbation (increase in cough, sputum or breathlessness, or change in the colour of sputum) within the preceding 2 weeks
- No weight loss in the preceding 2 weeks
- Healthy males and females who are age- weight- and sex- matched to the enrolled individuals with CF
- Can clearly state that they are not pregnant
- No clinical diagnosis of a chronic disease
- Can understand and cooperate with the study protocol
- No contraindications to performing exhaustive exercise
Who cannot join
- Any non-pulmonary conditions that may impair exercise ability, such as musculoskeletal disorders (arthritis, joint or muscle disease) and cardiovascular disease (congenital heart disease or cardiomyopathy).
- Unstable co-morbid asthma (daily pulmonary function variability of >20%)
- Is pregnant during the initial screening process
- Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
- Not of a suitable age for testing
- Is a smoker or inhales any other substances
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- Any pulmonary, metabolic or cardiovascular conditions
- Any other diagnosed disease
- Any non-pulmonary conditions that may impair exercise ability, such as musculoskeletal disorders (active arthritis, joint or muscle disease) and cardiovascular disease (congenital heart disease or cardiomyopathy)
- Is pregnant during the initial screening process
- Presents with co-morbidities to performing exhaustive exercise
- Is a smoker or inhales any other substances
- Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
- Not an age- weight- or sex-match for the CF group
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Portsmouth
Portsmouth, PO1 2EF
Zoe Saynor, 023 9284 3080 ext. 3080, zoe.saynor@port.ac.uk
Lauren Clayton, 023 9284 3085 ext. 3085, lauren.clayton@port.ac.uk
About this study
Official title: A Study to Assess the Sweat Response, Sweat Composition and Thermoregulatory Response to Exercise in Heat in Adults With Cystic Fibrosis on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy Compared Healthy Controls.
Cystic fibrosis (CF) is a common inherited condition in the Caucasian population resulting in poor function and/or production of the CF transmembrane conductance regulator (CFTR) protein. The CFTR protein plays a crucial role in the secretion and re-absorption of sodium chloride within the sweat gland. The sweat gland has played a key role in diagnosing and understanding CF with sweat chloride elevation being a key criterion to diagnosing CF. People with CF are thought to be at risk of exertional heat illness during exposure to hot environments or during prolonged periods of exercise and are currently encouraged to take salt supplements during periods of excessive sweating.
Kaftrio®, a newly approved pharmacological therapy has shown a rapid and sustained reduction in sweat chloride levels on initiation of this treatment. This study will aim to play a crucial part in understanding the sweat response, sweat composition and the thermoregulatory response to exercise in the heat in people with CF on Kaftrio®.
Read the detailed description
Cystic fibrosis (CF) is a common inherited condition in the Caucasian population, affecting approximately 52, 246 people in Europe. Mutations in the CF transmembrane conductance regulator (CFTR) gene results in poor function or production of the CFTR protein which functions as an anion channel to transport ions across the cell membrane.
The sweat gland has played a substantial part in diagnosing and understanding CF with sweat chloride elevation being a key criterion to diagnosing CF. Traditionally, abnormal function of the CFTR protein in the sweat gland results in failure to reabsorb sodium chloride leading to excessive salt loss. People with CF are thought to be at risk of exertional heat illness during exposure to hot environments or during prolonged periods of exercise and are currently encouraged to take salt supplements during periods of excessive sweating.
Over the last decade pharmacological therapies (CFTR modulator therapies (CFTRm)) which target the underlying cellular defect characterising CFTR in people with CF have been developed. Kaftrio® is now the most widely used modulator therapy. Studies have shown a rapid and sustained reduction in sweat chloride levels on initiation of these highly effective CFTRm. The need for salt supplementation may be influenced when taking CFTRm. Therefore, there is a need to further understand the sweat response relative to the needs in people with CF.
This study will recruit 9 people with CF who currently taking Kaftrio® and 9 healthy age-, sex- and weight-matched controls who are ≥ 18 years old. We will ask all participants to attend the laboratories for 2 visits. Visit 1 is designed to calculate metabolic heat production during different cycling intensities in order to set the workload for visit 2 relative to their metabolic heat production. Visit 2 is designed to collect sweat and thermoregulatory indices during 1 hour of cycling in the heat.
This study will compare the sweating and thermoregulatory response to exercising in the heat in a group of people with CF who are stable on Kaftrio® compared to a healthy matched control group.
The aims of this study are to:
- Determine the sweat sodium concentration in adults with CF on Kaftrio® from exercise at a fixed-rate of metabolic heat production under heat stress conditions and whether this is different to healthy age- weight- and sex- matched controls;
- Determine the local and whole-body sweat rate in adults with CF on Kaftrio® during exercise under heat stress conditions and whether this is different to healthy age- weight- and sex- matched controls;
- Determine how adults with CF on Kaftrio® respond in terms of skin blood flow during exercise under heat stress conditions and whether this is different to healthy age- weight- and sex- matched controls;
- Determine thermal strain from skin and core body temperature in adults with CF on Kaftrio® during exercise under heat stress conditions and whether this is different to healthy age- weight- and sex- matched controls.
- Conditions
- Cystic Fibrosis
- Keywords
- Exercise, CFTR modulator therapy, thermoregulation, heat-related illness, sweat sodium
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis | No intervention - only assessments | |
| Healthy Control | No intervention- only assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sweat sodium concentration (mmol∙L-1)
Between group differences in sweat sodium concentration
Measured: Day 2 - baseline
Secondary outcomes (16)
Whole-body sweat rate (mL)
Between group differences in whole-body sweat rate derived from pre - post nude body mass
Measured: Day 2 - baseline
Forearm sweat rate (mg∙min-1∙cm2)
Between group differences in forearm sweat rate
Measured: Day 2 - baseline
Mid-back sweat rate (mg∙min-1∙cm2)
Between group differences in mid-back sweat rate
Measured: Day 2 - baseline
Sweat gland activity (gland∙cm2)
Between group differences in sweat-gland activation derived from the modified-iodine patch technique
Measured: Day 2 - baseline
Core temperature (°C)
Between group differences in core temperature derived from rectal temperature
Measured: Day 2 - baseline
Mean skin temperature (°C)
Between group differences in skin temperature
Measured: Day 2 - baseline
Heart rate (b∙min-1)
Between group differences in heart rate
Measured: Day 2 - baseline
Cutaneous blood flux
Between group differences in cutaneous blood flux
Measured: Day 2 - baseline
Urine osmolality (mOsmol/kg)
Between group differences in urine osmolality
Measured: Day 2 - baseline
Perception of temperature sensation
Between group differences in perception of temperature sensation
Measured: Day 2 - baseline
Perception of thermal comfort
Between group differences in perception of thermal comfort
Measured: Day 2 - baseline
Change in thermal comfort
Between group differences in change in thermal comfort
Measured: Day 2 - baseline
Rate of change in thermal comfort
Between group differences in rate of change in thermal comfort
Measured: Day 2 - baseline
Heat sensitivity
Between group differences in heat sensitivity derived from sweat rate / change in thermal comfort
Measured: Day 2 - baseline
Heat illness symptom index
Between group differences in heat-related illness symptoms
Measured: Day 2 - baseline
Maximal oxygen uptake (VO2 max)
Between group differences in oxygen uptake derived from a maximal cardiopulmonary exercise test
Measured: Day 1 - baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start18 Mar 2023
- Primary completion18 Mar 2024 (estimated)
- Study completion18 Mar 2024 (estimated)
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Zoe Saynor, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896488
- Sponsor's protocol ID
- 315193
- Acronym
- Sweat-CF
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 9 Jun 2023
- 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 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Sweat Response, Sweat Composition and Thermoregulatory Response to Exercise in Heat in Adults With Cystic Fibrosis on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy Compared Healthy Controls.
- ClinicalTrials.gov ID
- NCT05896488
- Acronym / sponsor ID
- Sweat-CF / 315193
- Conditions
- Cystic Fibrosis
- Keywords
- Exercise, CFTR modulator therapy, thermoregulation, heat-related illness, sweat sodium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- 18 Mar 2024 (estimated)
- Study completion
- 18 Mar 2024 (estimated)
- First posted
- 9 Jun 2023 (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.
Cystic fibrosis (CF) is a common inherited condition in the Caucasian population resulting in poor function and/or production of the CF transmembrane conductance regulator (CFTR) protein. The CFTR protein plays a crucial role in the secretion and re-absorption of sodium chloride within the sweat gland. The sweat gland has played a key role in diagnosing and understanding CF with sweat chloride elevation being a key criterion to diagnosing CF. People with CF are thought to be at risk of exertional heat illness during exposure to hot environments or during prolonged periods of exercise and are currently encouraged to take salt supplements during periods of excessive sweating.
Kaftrio®, a newly approved pharmacological therapy has shown a rapid and sustained reduction in sweat chloride levels on initiation of this treatment. This study will aim to play a crucial part in understanding the sweat response, sweat composition and the thermoregulatory response to exercise in the heat in people with CF on Kaftrio®.
Detailed description
Cystic fibrosis (CF) is a common inherited condition in the Caucasian population, affecting approximately 52, 246 people in Europe. Mutations in the CF transmembrane conductance regulator (CFTR) gene results in poor function or production of the CFTR protein which functions as an anion channel to transport ions across the cell membrane.
The sweat gland has played a substantial part in diagnosing and understanding CF with sweat chloride elevation being a key criterion to diagnosing CF. Traditionally, abnormal function of the CFTR protein in the sweat gland results in failure to reabsorb sodium chloride leading to excessive salt loss. People with CF are thought to be at risk of exertional heat illness during exposure to hot environments or during prolonged periods of exercise and are currently encouraged to take salt supplements during periods of excessive sweating.
Over the last decade pharmacological therapies (CFTR modulator therapies (CFTRm)) which target the underlying cellular defect characterising CFTR in people with CF have been developed. Kaftrio® is now the most widely used modulator therapy. Studies have shown a rapid and sustained reduction in sweat chloride levels on initiation of these highly effective CFTRm. The need for salt supplementation may be influenced when taking CFTRm. Therefore, there is a need to further understand the sweat response relative to the needs in people with CF.
This study will recruit 9 people with CF who currently taking Kaftrio® and 9 healthy age-, sex- and weight-matched controls who are ≥ 18 years old. We will ask all participants to attend the laboratories for 2 visits. Visit 1 is designed to calculate metabolic heat production during different cycling intensities in order to set the workload for visit 2 relative to their metabolic heat production. Visit 2 is designed to collect sweat and thermoregulatory indices during 1 hour of cycling in the heat.
This study will compare the sweating and thermoregulatory response to exercising in the heat in a group of people with CF who are stable on Kaftrio® compared to a healthy matched control group.
The aims of this study are to:
- Determine the sweat sodium concentration in adults with CF on Kaftrio® from exercise at a fixed-rate of metabolic heat production under heat stress conditions and whether this is different to healthy age- weight- and sex- matched controls;
- Determine the local and whole-body sweat rate in adults with CF on Kaftrio® during exercise under heat stress conditions and whether this is different to healthy age- weight- and sex- matched controls;
- Determine how adults with CF on Kaftrio® respond in terms of skin blood flow during exercise under heat stress conditions and whether this is different to healthy age- weight- and sex- matched controls;
- Determine thermal strain from skin and core body temperature in adults with CF on Kaftrio® during exercise under heat stress conditions and whether this is different to healthy age- weight- and sex- matched controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis | – | –No intervention - only assessments |
| Healthy Control | – | –No intervention- only assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from adult CF outpatient clinics within the CF network. If a potential participant outside of the CF network wishes to participant they will be screened by the CF consultants within the CF network.
Key inclusion criteria (13 listed)
- Is taking CFTRm
- Males and females ≥ 18 years of age
- CF diagnosis based on clinical features, supported by a history of an abnormal sweat test (sweat [Cl-] > 60 mmol·L-1 > 100 mg sweat), where possible, diagnostic genotyping would also be desired
- Can clearly state that they are not pregnant
- No contraindications to performing exhaustive exercise
Key exclusion criteria (14 listed)
- Any non-pulmonary conditions that may impair exercise ability, such as musculoskeletal disorders (arthritis, joint or muscle disease) and cardiovascular disease (congenital heart disease or cardiomyopathy).
- Unstable co-morbid asthma (daily pulmonary function variability of >20%)
- Is pregnant during the initial screening process
- Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
- Not of a suitable age for testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sweat sodium concentration (mmol∙L-1)
Time frame: Day 2 - baseline
Between group differences in sweat sodium concentration
16 secondary outcomes
Whole-body sweat rate (mL)
Time frame: Day 2 - baseline
Forearm sweat rate (mg∙min-1∙cm2)
Time frame: Day 2 - baseline
Mid-back sweat rate (mg∙min-1∙cm2)
Time frame: Day 2 - baseline
Sweat gland activity (gland∙cm2)
Time frame: Day 2 - baseline
Core temperature (°C)
Time frame: Day 2 - baseline
Mean skin temperature (°C)
Time frame: Day 2 - baseline
Heart rate (b∙min-1)
Time frame: Day 2 - baseline
Cutaneous blood flux
Time frame: Day 2 - baseline
Urine osmolality (mOsmol/kg)
Time frame: Day 2 - baseline
Perception of temperature sensation
Time frame: Day 2 - baseline
Perception of thermal comfort
Time frame: Day 2 - baseline
Change in thermal comfort
Time frame: Day 2 - baseline
Rate of change in thermal comfort
Time frame: Day 2 - baseline
Heat sensitivity
Time frame: Day 2 - baseline
Heat illness symptom index
Time frame: Day 2 - baseline
Maximal oxygen uptake (VO2 max)
Time frame: Day 1 - baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
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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?
An observational study of Cystic Fibrosis, run by University of Portsmouth at 1 site in United Kingdom.
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 13 inclusion and 14 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 9 Jun 2023. 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 United Kingdom. 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 Zoe Saynor (02392843080, zoe.saynor@port.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sweat sodium concentration (mmol∙L-1) (time frame: Day 2 - baseline). 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 9 Jun 2023.