Sweat Evaporimeter Measurement

Launched by UNIVERSITY OF COLORADO, DENVER · Oct 16, 2012

Keywords

ClinConnect Summary

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 channe...

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Eligibility 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.