Nasal Potential Difference (NPD) for the Diagnosis of Cystic Fibrosis

NCT00589745 | Completed

• 1 other identifier: 98-001589
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to provide a novel method for the diagnosis of Cystic Fibrosis (CF). This protocol is designed to test the ability of the cells to regulate the movement of salt and water in people with features of CF in whom the diagnosis is not entirely clear. We will be studying these cells in the nose, by a technique called nasal transepithelial potential difference (NPD).

Conditions

Cystic Fibrosis

Keywords

Diagnosis

Outcome Measures

Primary Outcomes (1)

• The basis of analysis will be the NPD response patterns, which will be interpreted and classified by the PI, as consistent or inconsistent with the diagnosis of CF based on comparison with published standards.

  Every visit

Study Arms (1)

Subjects being evaluated for CF

OTHER

Subjects will be referred from physicians who are clinically concerned about the possibility of Cystic Fibrosis. Nasal potential difference measurement will be obtained to potentially help aid in diagnosis.

Other: Nasal potential difference measurement

Interventions

Nasal potential difference measurement OTHER

Nasal potential difference measurement involves dripping small amounts of 5 test solutions into the anterior nostril. This is designed to test the ability of the cells to regulate the movement of salt and water in people with features of CF in whom the diagnosis is not entirely clear.

Also known as: NPD

Subjects being evaluated for CF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All ethnic groups accepted
• Individuals with borderline or normal sweat chloride, one or no identified CFTR mutations and a clinical history suggestive of CF.
• Children less than 6-8 years of age may be unable to cooperate (hold still) for the procedure, or be frightened by the procedure. Sedation may be necessary for performance of the procedure on a young child

You may not qualify if:

• n/a

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Disease

Interventions

neodymium pyrocatechin disulfonate

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald Rubenstein, M.D., PhD.

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 10, 2008
• Study Start: September 1, 2003
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

US (1)