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Completed

NCT Number: NCT01708655

Sweat Evaporimeter Measurement

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sweat Evaporimeter measurement

Other
  • 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

Evaluation of the Accuracy and Reliability of B-Adrenergic Sweat Secretion Using an Evaporimeter to Assess CFTR Function in Cystic Fibrosis

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 17, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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