A Study of Sweat Testing Using a Quantitative Patch

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT01345617
• Lead Sponsor: Polychrome Medical, Inc.

Brief Summary

The primary aim of the study is to determine if the CF Quantum Sweat Test provides sweat chloride results that are equivalent to the results from traditional sweat testing. The secondary aim of the study is to assess the quantity not sufficient rate of the CF Quantum Sweat Test compared to traditional sweat testing.

Detailed Description

All 50 states and the District of Columbia are performing newborn screening for cystic fibrosis (CF). Infants who have a positive newborn screen require follow-up with a sweat test. Gibson-Cooke Quantitative Pilocarpine Iontophoresis (GCQPIT) requires collecting sweat in microbore tubing or on gauze/filter paper and analyzing sweat using a chloridometer. This test has many difficulties including specimens that are quantity not sufficient (QNS), many steps of pipetting solutions in the laboratory, and the need for a chloridometer to analyze sweat chloride concentration. The only manufacturer of a chloridometer has ceased production of this instrument. The CF Quantum® Sweat Test System (CFQT) overcomes all of the difficulties of GCQPIT. This pilot study will determine if the CFQT provides results that are equivalent to GCQPIT.

Study Timeline

• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Study Start: 2012-01
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• clinical diagnosis of cystic fibrosis
• patients who require a sweat test

Exclusion Criteria

• Infants less than 48 hours of age
• Patient is receiving oxygen by open delivery
• collection site has diffuse inflammation or rash

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sweat chloride value	once, at enrollment (baseline)	Sweat chloride measurements obtained by GCQPIT and CFQT

Secondary Outcome Measures

Name	Time	Method
QNS rate	once, at enrollment (baseline)	QNS rate of CFQT compared to GCQPIT

Trial Locations

Locations (3)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

American Family Children's Hospital; 🇺🇸 Madison, Wisconsin, United States