<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01708655</url>
  </required_header>
  <id_info>
    <org_study_id>11-1463</org_study_id>
    <nct_id>NCT01708655</nct_id>
  </id_info>
  <brief_title>Sweat Evaporimeter Measurement</brief_title>
  <official_title>Evaluation of the Accuracy and Reliability of B-Adrenergic Sweat Secretion Using an Evaporimeter to Assess CFTR Function in Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cystic Fibrosis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that measurement of beta adrenergic induced sweat rate using an&#xD;
      evaporimeter can accurately and reliably determine different levels of CFTR dysfunction&#xD;
      within a spectrum of patients expressing various degrees of cystic fibrosis disease.&#xD;
&#xD;
      The investigators overall goal is to determine whether the evaporimeter technique of&#xD;
      measuring beta-adrenergic induced sweat rate is capable of accurately and reliably&#xD;
      identifying different levels of CFTR dysfunction, as a prerequisite before advancing this&#xD;
      technique as biomarker assay into clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preliminary data show that following β-adrenergic stimulation, evaporimetry can reliably&#xD;
      measure sweat secretion that is: highly reproducible in healthy controls; reduced by 50% in&#xD;
      CF obligate heterozygotes; and absent in CF patients carrying severe mutations on both&#xD;
      alleles. Further, test- retest experiments suggest good intra-individual reliability. All&#xD;
      these features satisfy the required criteria for a biomarker assay that is capable of&#xD;
      assessing small increments in CFTR function in vivo in clinical trials designed to assess the&#xD;
      effectiveness of correctors and potentiators of CFTR channel activity. Therefore, to provide&#xD;
      additional evidence of the value of this novel technique the investigators will determine the&#xD;
      accuracy and reliability of evaporimetry to measure Beta-adrenergic induced sweating in&#xD;
      subjects with a range of CFTR channel activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <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.</measure>
    <time_frame>Up to 2 hours</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Sweat Evaporimeter measurement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>0.1 ml Carbachol, intraocular solution - diluted to 0.1 µg/ml in normal saline- dose 0.01 µg&#xD;
0.2 ml Atropine sulphate, injection solution - diluted to 44 µg/ml in normal saline - dose 8.8 µg.&#xD;
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:&#xD;
4.4 µg Isoproterenol hydrochloride, injection solution&#xD;
0.93 mg Aminophylline injection solution&#xD;
8.8 µg Atropine, injection solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sweat Evaporimeter measurement</intervention_name>
    <description>The forearm will be cleaned with distilled water. Mineral oil will be applied to the surface of the skin after each injection.&#xD;
intracutaneous injection of 0.2 ml of atropine&#xD;
Stimulation and inhibition of sweating in an adjoining &quot;test&quot; area. Assessment of sweat secretion with an evaporimeter for 10 minutes after:&#xD;
Intracutaneous injection of 0.1 ml carbachol for stimulation of the cholinergic sweat secretion.&#xD;
intracutaneous injection of 0.2 ml atropine to Inhibit cholinergic sweat secretion&#xD;
intracutaneous injection of 0.2 ml beta-cocktail (atropine isoproterenol and aminophylline) for stimulation of beta-adrenergic sweat secretion .&#xD;
The procedure would take about 45 minutes.</description>
    <arm_group_label>Sweat Evaporimeter measurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female ages 18 years and older.&#xD;
&#xD;
          2. Subject with or without confirmed diagnosis of CF.&#xD;
&#xD;
          3. Written informed consent obtained from subject.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are participating in clinical trials evaluating the safety, efficacy or&#xD;
             clinical outcome of drugs that may alter the CFTR Cl channel function will be&#xD;
             excluded.&#xD;
&#xD;
          2. Any subject with a known hypersensitivity to any agonist used in the study or subjects&#xD;
             receiving any drug (e.g. theophylline, antihypertensive agent) that might interfere&#xD;
             with the investigations.&#xD;
&#xD;
          3. Subjects with active dermatitis or other chronic skin condition such as psoriasis or a&#xD;
             strong allergic history.&#xD;
&#xD;
          4. Patients with a history of cardiac disease (including arrhythmias or hypertrophic&#xD;
             obstructive cardiomyopathy).&#xD;
&#xD;
          5. CF patients with severe malnutrition (BMI&lt;18 kg/m2).&#xD;
&#xD;
          6. CF patients with severe lung disease (FEV1&lt;25%).&#xD;
&#xD;
          7. Subject who has been treated for pulmonary exacerbation or other acute illness within&#xD;
             one week of the study procedure.&#xD;
&#xD;
          8. Any medical condition that, in the opinion of the investigator, will interfere with&#xD;
             accurate conduct of the study.&#xD;
&#xD;
          9. Subjects who are pregnant or lactating.&#xD;
&#xD;
         10. Subject who is not able to stop inhalation therapy of β -adrenergic drugs 12 hrs&#xD;
             before starting each test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank J Accurso, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Colorado</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>December 1, 2014</last_update_submitted>
  <last_update_submitted_qc>December 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cystic Fibrosis</keyword>
  <keyword>Sweat Evaporimeter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01708655
org study id: 11-1463
nct id: NCT01708655
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
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
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.
arm group label: Sweat Evaporimeter measurement
arm group type: Other
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: Sweat Evaporimeter measurement
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.
arm group label: Sweat Evaporimeter measurement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frank J Accurso, MD
role: Principal Investigator
affiliation: Children's Hospital Colorado
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis