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

September 28, 2012
March 6, 2013
December 2011
April 2013   (final data collection date for 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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01708655 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sweat Evaporimeter Measurement
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 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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cystic Fibrosis
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.

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
Intervention: Other: Sweat Evaporimeter measurement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
December 2016
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01708655
11-1463
Yes
University of Colorado, Denver
University of Colorado, Denver
Cystic Fibrosis Foundation
Principal Investigator: Frank J Accurso, MD Children's Hospital Colorado
University of Colorado, Denver
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP