Absorptive Clearance in the Cystic Fibrosis Airway - Full Text View

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00541190

Purpose

The objective of this study is to develop a new aerosol-based technique for quantifying liquid absorption in the airways of subjects with cystic fibrosis(CF) that can be used to help develop new therapies. In CF, mutations in the CF gene result in dysfunction of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) ion channel on the cells that line the airway epithelium, causing improper fluxes of ions such as sodium, chloride, and bicarbonate. The so called "low volume" hypothesis of CF pathogenesis contends that abnormal absorption of ions from the airways causes excessive absorption of liquid, resulting in an airway surface liquid layer that is dehydrated and difficult to clear. Here we are trying to develop a means of measuring liquid absorption from the airways so that therapies that would propose to correct this basic defect of CF lung disease can be effectively tested.

Condition	Intervention
Cystic Fibrosis	Other: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Absorptive Clearance in the Cystic Fibrosis Airway

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Absorptive Clearance Rate [ Time Frame: single measurement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mucociliary Clearance Rate [ Time Frame: single measurement ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Aerosol Clearance Scan

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Cystic fibrosis subjects and healthy controls
Age ≥ 18 years
Diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical symptoms (CF subjects)
Clinically stable as determined by the investigator (pulmonologist)

Exclusion Criteria:

Reactive airways disease
Tobacco smokers (regular smoking within 6 months of enrollment)
Positive urine pregnancy test on the day of testing
FEV1p value of < 50%
SaO2 < 92%, or if they require supplemental oxygen.
Subjects performing other radioisotope studies within the last 2 weeks will be excluded.
Healthy subjects with any history of lung disease will be excluded.
Women currently breastfeeding
Subjects not willing to stop treatments with inhaled hypertonic saline for 48 hours in advance of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541190

Locations

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Timothy E Corcoran, Ph.D.

University of Pittsburgh

More Information

Responsible Party:	University of Pittsburgh ( Tim Corcoran, Ph.D. )
Study ID Numbers:	PRO07060240, NIH K25 HL081533-02
Study First Received:	October 5, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00541190
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

cystic fibrosis
mucociliary clearance
outcome measures

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009