A Study of Sweat Testing Using a Quantitative Patch

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis

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 Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Utah
    • Salt Lake City, Utah, United States, 84012
      • University of Utah
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • American Family Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

pediatric pulmonology clinic

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
cystic fibrosis patients
non-cystic fibrosis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sweat chloride value	Sweat chloride measurements obtained by GCQPIT and CFQT	once, at enrollment (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QNS rate	QNS rate of CFQT compared to GCQPIT	once, at enrollment (baseline)

Collaborators and Investigators

• Sponsor: Polychrome Medical, Inc.
• Investigators: Principal Investigator: Michael J Rock, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis
• Other Study ID Numbers: 2011-0291; CFQuantum001 (Other Identifier: PolyChrome Medical, Inc.)