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Sweat Evaporimeter Measurement

NCT ID: NCT01708655

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Sweat Evaporimeter measurement

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank J Accurso, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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11-1463

Identifier Type: -

Identifier Source: org_study_id