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Sweat Evaporimeter Measurement

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sweat Evaporimeter measurement
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Sweat Evaporimeter

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male or female ages 18 years and older.
  2. Subject with or without confirmed diagnosis of CF.
  3. Written informed consent obtained from subject.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Subjects with active dermatitis or other chronic skin condition such as psoriasis or a strong allergic history.
  4. Patients with a history of cardiac disease (including arrhythmias or hypertrophic obstructive cardiomyopathy).
  5. CF patients with severe malnutrition (BMI<18 kg/m2).
  6. CF patients with severe lung disease (FEV1<25%).
  7. Subject who has been treated for pulmonary exacerbation or other acute illness within one week of the study procedure.
  8. Any medical condition that, in the opinion of the investigator, will interfere with accurate conduct of the study.
  9. Subjects who are pregnant or lactating.
  10. Subject who is not able to stop inhalation therapy of β -adrenergic drugs 12 hrs before starting each test.

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sweat Evaporimeter measurement

Arm Description

0.1 ml Carbachol, intraocular solution - diluted to 0.1 µg/ml in normal saline- dose 0.01 µg 0.2 ml Atropine sulphate, injection solution - diluted to 44 µg/ml in normal saline - dose 8.8 µg. 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2012
Last Updated
December 1, 2014
Sponsor
University of Colorado, Denver
Collaborators
Cystic Fibrosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01708655
Brief Title
Sweat Evaporimeter Measurement
Official Title
Evaluation of the Accuracy and Reliability of B-Adrenergic Sweat Secretion Using an Evaporimeter to Assess CFTR Function in Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Cystic Fibrosis Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, Sweat Evaporimeter

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sweat Evaporimeter measurement
Arm Type
Other
Arm Description
0.1 ml Carbachol, intraocular solution - diluted to 0.1 µg/ml in normal saline- dose 0.01 µg 0.2 ml Atropine sulphate, injection solution - diluted to 44 µg/ml in normal saline - dose 8.8 µg. 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
Intervention Type
Other
Intervention Name(s)
Sweat Evaporimeter measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Up to 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female ages 18 years and older. Subject with or without confirmed diagnosis of CF. Written informed consent obtained from subject. Exclusion Criteria: 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%). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank J Accurso, MD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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Sweat Evaporimeter Measurement

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