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Repeatability and Response Study of Absorptive Clearance Scans

Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Absorptive clearance scan (Other); inhaled hypertonic saline (7%) (Drug); mannitol inhalation powder (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Tim Corcoran, Ph.D., Principal Investigator, Affiliation: University of Pittsburgh

Overall contact:
Adrienne DeRicco, RN, Phone: 1-877-296-9026, Email: Adrienne.DeRicco@chp.edu

Summary

The investigators are developing a new nuclear medicine imaging technique for measuring liquid absorption in the airways that can be applied to screen new medications being developed to treat cystic fibrosis (CF). The investigators believe that the absorption of the small molecule radiopharmaceutical Indium 111 diethylene triamine pentaacetic acid (In-DTPA) will indicate changes in liquid absorption in the airways and demonstrate whether new CF medications will be effective. In this study the investigators will determine whether the imaging technique will demonstrate similar results when it is repeated on different days. They will also determine how their results change when subjects utilize several common CF medications.

Clinical Details

Official title: Repeatability and Response Study of Absorptive Clearance Scans

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

absorptive clearance variability

absorptive clearance response

Detailed description: Cystic Fibrosis (CF) is an autosomal recessive genetic disease, caused by mutations of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) that impairs ion transport at epithelial surfaces. This results in the accumulation of dehydrated secretions in the airways and chronic infection and inflammation in the lungs, leading to significant morbidity and mortality. The investigators understanding of CF pathogenesis has increased substantially and many new targeted therapies are being developed to treat this disease, however, the measurements of clinical efficacy used to evaluate these therapies require long trials to demonstrate an effect. New translational techniques are needed to assess changes in the most basic aspects of the disease and allow for the rapid screening of disease-altering therapies. The investigators have recently developed a novel aerosol-based

imaging technique to measure liquid absorption in the airways - a central pathophysiological

process related to CFTR dysfunction. The investigators propose that airway liquid hyper-absorption is a key link between cellular defects in ion and fluid transport and progressive airway dysfunction in CF. Thus The investigators technique may provide a measure of disease severity and rapid indication of therapeutic correction in advance of currently available outcome measures.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- subjects 18 years old or older with a diagnosis of cystic fibrosis as determined by

sweat test or genotype and clinical symptoms who are clinically stable as determined by a physician co-investigator Exclusion Criteria:

- one second forced expiratory volume (FEV1) <50% of predicted

- nursing mother

- positive urine pregnancy test or unwilling to test

- cigarette smoker

- unwilling to stop hypertonic saline therapy for 72 hours prior to each test day

- are intolerant to hypertonic saline (response only)

- are intolerant to any inhaled therapies (response only)

- fail mannitol tolerance testing (response only)

- have a history of excessive (uncontrollable) coughing after an osmotic stimulus

(response only)

- have a history of hemoptysis (response only)

Locations and Contacts

Adrienne DeRicco, RN, Phone: 1-877-296-9026, Email: Adrienne.DeRicco@chp.edu

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Adrienne DeRicco, RN, Phone: 877-296-9026, Email: Adrienne.DeRicco@chp.edu
Tim Corcoran, Ph.D., Principal Investigator
Additional Information

Dr. Corcoran's Research Page

Related publications:

Corcoran TE, Thomas KM, Brown S, Myerburg MM, Locke LW, Pilewski JM. Liquid hyper-absorption as a cause of increased DTPA clearance in the cystic fibrosis airway. EJNMMI Res. 2013 Feb 27;3(1):14. doi: 10.1186/2191-219X-3-14.

Corcoran TE, Thomas KM, Myerburg MM, Muthukrishnan A, Weber L, Frizzell R, Pilewski JM. Absorptive clearance of DTPA as an aerosol-based biomarker in the cystic fibrosis airway. Eur Respir J. 2010 Apr;35(4):781-6. doi: 10.1183/09031936.00059009. Epub 2009 Aug 28.

Starting date: June 2013
Last updated: April 9, 2014

Page last updated: August 23, 2015

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