A Study of Sweat Testing Using a Quantitative Patch

• ClinicalTrials.gov Identifier: NCT01345617
• Recruitment Status: Completed
• First Posted: May 2, 2011
• Last Update Posted: August 29, 2018
• Sponsor: Polychrome Medical, Inc.
• Information provided by (Responsible Party): Polychrome Medical, Inc.

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 170 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: A Study of Sweat Testing Using a Quantitative Patch
• Study Start Date: January 2012
• Actual Primary Completion Date: October 2013
• Actual Study Completion Date: October 2013

Groups and Cohorts

Group/Cohort
cystic fibrosis patients; cystic fibrosis patients
non-cystic fibrosis patients; non-cystic fibrosis patients

Outcome Measures

Primary Outcome Measures :

1. sweat chloride value [ Time Frame: once, at enrollment (baseline) ]
   Sweat chloride measurements obtained by GCQPIT and CFQT

Secondary Outcome Measures :

1. QNS rate [ Time Frame: once, at enrollment (baseline) ]
   QNS rate of CFQT compared to GCQPIT

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

pediatric pulmonology clinic

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84012

United States, Wisconsin

American Family Children's Hospital

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Polychrome Medical, Inc.

Investigators

• Principal Investigator: Michael J Rock, MD; University of Wisconsin, Madison

More Information

• Responsible Party: Polychrome Medical, Inc.
• ClinicalTrials.gov Identifier: NCT01345617
• Other Study ID Numbers: 2011-0291; CFQuantum001 ( Other Identifier: PolyChrome Medical, Inc. )
• First Posted: May 2, 2011
• Last Update Posted: August 29, 2018
• Last Verified: August 2018

Additional relevant MeSH terms:

Cystic Fibrosis; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases