Sweat Evaporimeter Measurement

NCT01708655 | Completed DMC

• 1 other identifier: 11-1463
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Sweat Evaporimeter

Outcome Measures

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.

  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.

  Up to 2 hours

Study Arms (1)

Sweat Evaporimeter measurement

OTHER

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

Interventions

Sweat Evaporimeter measurement OTHER

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Frank J Accurso, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 17, 2012
• Study Start: December 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

US (1)