Sweat Evaporimeter Measurement

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01708655
First received: September 28, 2012
Last updated: March 6, 2013
Last verified: October 2012
  Purpose

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 CF 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.


Condition Intervention
Cystic Fibrosis
Other: Sweat Evaporimeter measurement

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of the Accuracy and Reliability of B-Adrenergic Sweat Secretion Using an Evaporimeter to Assess CFTR Function in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

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. [ Time Frame: Up to 2 hours ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sweat Evaporimeter measurement
  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
Other: Sweat Evaporimeter measurement
  1. 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708655

Locations
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Cystic Fibrosis Foundation
Investigators
Principal Investigator: Frank J Accurso, MD Children's Hospital Colorado
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01708655     History of Changes
Other Study ID Numbers: 11-1463
Study First Received: September 28, 2012
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Cystic Fibrosis
Sweat Evaporimeter

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014