Cystic FibrosisNCT01708655
Sweat Evaporimeter Measurement
A study testing Sweat Evaporimeter measurement in people with Cystic Fibrosis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators hypothesize that measurement of beta adrenergic induced sweat rate using an evaporimeter can accurately and reliably determine different levels of CFTR dysfunction within a spectrum of patients expressing various degrees of cystic fibrosis disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Sweat Evaporimeter measurement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female ages 18 years and older.
- Subject with or without confirmed diagnosis of CF.
- Written informed consent obtained from subject.
Who cannot join
- Patients who are participating in clinical trials evaluating the safety, efficacy or clinical outcome of drugs that may alter the CFTR Cl channel function will be excluded.
- Any subject with a known hypersensitivity to any agonist used in the study or subjects receiving any drug (e.g. theophylline, antihypertensive agent) that might interfere with the investigations.
- Subjects with active dermatitis or other chronic skin condition such as psoriasis or a strong allergic history.
- Patients with a history of cardiac disease (including arrhythmias or hypertrophic obstructive cardiomyopathy).
- CF patients with severe malnutrition (BMI<18 kg/m2).
- CF patients with severe lung disease (FEV1<25%).
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- Subject who has been treated for pulmonary exacerbation or other acute illness within one week of the study procedure.
- Any medical condition that, in the opinion of the investigator, will interfere with accurate conduct of the study.
- Subjects who are pregnant or lactating.
- Subject who is not able to stop inhalation therapy of β -adrenergic drugs 12 hrs before starting each test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Evaluation of the Accuracy and Reliability of B-Adrenergic Sweat Secretion Using an Evaporimeter to Assess CFTR Function in Cystic Fibrosis
The investigators hypothesize that measurement of beta adrenergic induced sweat rate using an evaporimeter can accurately and reliably determine different levels of CFTR dysfunction within a spectrum of patients expressing various degrees of cystic fibrosis disease.
The investigators overall goal is to determine whether the evaporimeter technique of measuring beta-adrenergic induced sweat rate is capable of accurately and reliably identifying different levels of CFTR dysfunction, as a prerequisite before advancing this technique as biomarker assay into clinical trials.
Read the detailed description
Preliminary data show that following β-adrenergic stimulation, evaporimetry can reliably measure sweat secretion that is: highly reproducible in healthy controls; reduced by 50% in CF obligate heterozygotes; and absent in CF patients carrying severe mutations on both alleles. Further, test- retest experiments suggest good intra-individual reliability. All these features satisfy the required criteria for a biomarker assay that is capable of assessing small increments in CFTR function in vivo in clinical trials designed to assess the effectiveness of correctors and potentiators of CFTR channel activity. Therefore, to provide additional evidence of the value of this novel technique the investigators will determine the accuracy and reliability of evaporimetry to measure Beta-adrenergic induced sweating in subjects with a range of CFTR channel activity.
- Conditions
- Cystic Fibrosis
- Being tested
- Sweat Evaporimeter measurement
- Keywords
- Cystic Fibrosis, Sweat Evaporimeter
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweat Evaporimeter measurementOther
- The forearm will be cleaned with distilled water. Mineral oil will be applied to the surface of the skin after each injection.
- intracutaneous injection of 0.2 ml of atropine
- Stimulation and inhibition of sweating in an adjoining "test" area. Assessment of sweat secretion with an evaporimeter for 10 minutes after:
- Intracutaneous injection of 0.1 ml carbachol for stimulation of the cholinergic sweat secretion.
- intracutaneous injection of 0.2 ml atropine to Inhibit cholinergic sweat secretion
- intracutaneous injection of 0.2 ml beta-cocktail (atropine isoproterenol and aminophylline) for stimulation of beta-adrenergic sweat secretion .
The procedure would take about 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Sweat Evaporimeter measurement | Other | 1. 0.1 ml Carbachol, intraocular solution - diluted to 0.1 µg/ml in normal saline- dose 0.01 µg
2. 0.2 ml Atropine sulphate, injection solution - diluted to 44 µg/ml in normal saline - dose 8.8 µg.
3. 0.2 ml of the Beta cocktail injection solution diluted to 44 µg/ml atropine, 22 µg/ml isoproterenol and 4.6 mg/ml aminophylline in normal saline - dose:
* 4.4 µg Isoproterenol hydrochloride, injection solution
* 0.93 mg Aminophylline injection solution
* 8.8 µg Atropine, injection solution Receives: Other: Sweat Evaporimeter measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of beta-adrenergic induced sweat rate using an evaporimeter can accurately and reliably determine different levels of CFTR dysfunction within a spectrum of patients expressing various degrees of CF disease.
The response patterns will be interpreted and classified by the study PI, as consistent or inconsistent to the published standards. The obtained measurements will be compared to the results obtained from a recently finished validation trial. According to the result of this trial the ranges were as followed: cholinergic response for all subjects 60±20 Evaporimeter units, beta-adrenergic response: Healthy control 51 ± 20 heterozygote -22 ±20, CF -1.4 ±2.
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2014
- Study completionDec 2014
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.
- More trials run by University of Colorado, DenverThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Frank J Accurso, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708655
- Sponsor's protocol ID
- 11-1463
- Status last verified
- Dec 2014
- First submitted
- 28 Sep 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy and Reliability of B-Adrenergic Sweat Secretion Using an Evaporimeter to Assess CFTR Function in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01708655
- Acronym / sponsor ID
- 11-1463
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Sweat Evaporimeter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Dec 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Oct 2012 (estimated)
- 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 investigators hypothesize that measurement of beta adrenergic induced sweat rate using an evaporimeter can accurately and reliably determine different levels of CFTR dysfunction within a spectrum of patients expressing various degrees of cystic fibrosis disease.
The investigators overall goal is to determine whether the evaporimeter technique of measuring beta-adrenergic induced sweat rate is capable of accurately and reliably identifying different levels of CFTR dysfunction, as a prerequisite before advancing this technique as biomarker assay into clinical trials.
Detailed description
Preliminary data show that following β-adrenergic stimulation, evaporimetry can reliably measure sweat secretion that is: highly reproducible in healthy controls; reduced by 50% in CF obligate heterozygotes; and absent in CF patients carrying severe mutations on both alleles. Further, test- retest experiments suggest good intra-individual reliability. All these features satisfy the required criteria for a biomarker assay that is capable of assessing small increments in CFTR function in vivo in clinical trials designed to assess the effectiveness of correctors and potentiators of CFTR channel activity. Therefore, to provide additional evidence of the value of this novel technique the investigators will determine the accuracy and reliability of evaporimetry to measure Beta-adrenergic induced sweating in subjects with a range of CFTR channel activity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sweat Evaporimeter measurement | Other | Other: Sweat Evaporimeter measurement1. 0.1 ml Carbachol, intraocular solution - diluted to 0.1 µg/ml in normal saline- dose 0.01 µg 2. 0.2 ml Atropine sulphate, injection solution - diluted to 44 µg/ml in normal saline - dose 8.8 µg. 3. 0.2 ml of the Beta cocktail injection solution diluted to 44 µg/ml atropine, 22 µg/ml isoproterenol and 4.6 mg/ml aminophylline in normal saline - dose: * 4.4 µg Isoproterenol hydrochloride, injection solution * 0.93 mg Aminophylline injection solution * 8.8 µg Atropine, injection solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ages 18 years and older.
- Subject with or without confirmed diagnosis of CF.
- Written informed consent obtained from subject.
Key exclusion criteria (10 listed)
- Patients who are participating in clinical trials evaluating the safety, efficacy or clinical outcome of drugs that may alter the CFTR Cl channel function will be excluded.
- Any subject with a known hypersensitivity to any agonist used in the study or subjects receiving any drug (e.g. theophylline, antihypertensive agent) that might interfere with the investigations.
- Subjects with active dermatitis or other chronic skin condition such as psoriasis or a strong allergic history.
- Patients with a history of cardiac disease (including arrhythmias or hypertrophic obstructive cardiomyopathy).
- CF patients with severe malnutrition (BMI<18 kg/m2).
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 |
|---|---|---|
| Sweat Evaporimeter measurement1. The forearm will be cleaned with distilled water. Mineral oil will be applied to the surface of the skin after each injection. 2. intracutaneous injection of 0.2 ml of atropine 3. Stimulation and inhibition of sweating in an adjoining "test" area. Assessment of sweat secretion with an evaporimeter for 10 minutes after: 1. Intracutaneous injection of 0.1 ml carbachol for stimulation of the cholinergic sweat secretion. 2. intracutaneous injection of 0.2 ml atropine to Inhibit cholinergic sweat secretion 3. intracutaneous injection of 0.2 ml beta-cocktail (atropine isoproterenol and aminophylline) for stimulation of beta-adrenergic sweat secretion . The procedure would take about 45 minutes. | Other | Sweat Evaporimeter measurement |
Primary outcome
Measurement of beta-adrenergic induced sweat rate using an evaporimeter can accurately and reliably determine different levels of CFTR dysfunction within a spectrum of patients expressing various degrees of CF disease.
Time frame: Up to 2 hours
The response patterns will be interpreted and classified by the study PI, as consistent or inconsistent to the published standards. The obtained measurements will be compared to the results obtained from a recently finished validation trial. According to the result of this trial the ranges were as followed: cholinergic response for all subjects 60±20 Evaporimeter units, beta-adrenergic response: Healthy control 51 ± 20 heterozygote -22 ±20, CF -1.4 ±2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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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.
Frank J Accurso, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sweat Evaporimeter measurement in people with Cystic Fibrosis, run by University of Colorado, Denver at 1 site in United States.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 3 Dec 2014. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of beta-adrenergic induced sweat rate using an evaporimeter can accurately and reliably determine different levels of CFTR dysfunction within a spectrum of patients expressing various degrees of CF disease. (time frame: Up to 2 hours). 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 3 Dec 2014; AzTrials last refreshed its copy on 28 Oct 2026.