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Absorptive Clearance in the Cystic Fibrosis Airway

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00541190
First received: October 5, 2007
Last updated: January 3, 2012
Last verified: January 2012
History of Changes
  Purpose

The objective of this overall project 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 measuring the absorption rate of a radiolabeled small molecule (DTPA) from the lungs of cystic fibrosis patients and healthy controls. We hypothesize that the molecule will absorb more quickly in cystic fibrosis patients. Further studies will be performed to determine if DTPA absorption is related to liquid absorption in the airways.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Absorptive Clearance in the Cystic Fibrosis Airway

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Absorptive Clearance Rate [ Time Frame: single measurement ] [ Designated as safety issue: No ]
    The absorptive clearance rate is the percentage of the radiolabeled small molecule DTPA that is cleared through absorption over a 60 minute period. Total DTPA clearance includes absorptive and mucociliary components. The mucociliary component is determined by measuring the clearance of a radiolabeled particle over the same period (Technetium 99m sulfur colloid; Tc-SC), and subtracted from total DTPA clearance in order to determine the absorptive component. Here we specifically report absorption from the central lung zone to capture the behavior within the airways.


Secondary Outcome Measures:
  • Mucociliary Clearance Rate [ Time Frame: single measurement ] [ Designated as safety issue: No ]
    Mucociliary clearance rate represents the rate at which the lungs clear an inhaled particulate. Here it specifically represents the percentage of inhaled Technetium 99m sulfur colloid cleared from the lungs over a 60 minute period. This is reported based on "whole lung" areas to allow comparisons with previous studies.


Enrollment: 21
Study Start Date: October 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cystic fibrosis
Cystic fibrosis patients
 Other: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA
Subjects perform a single nuclear medicine scan after inhaling an aerosol containing Technetium 99m sulfur colloid and Indium 111 DTPA.
Experimental: healthy controls
Healthy control subjects
 Other: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA
Subjects perform a single nuclear medicine scan after inhaling an aerosol containing Technetium 99m sulfur colloid and Indium 111 DTPA.

  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

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00541190     History of Changes
Other Study ID Numbers: PRO07060240, NIH K25 HL081533-02
Study First Received: October 5, 2007
Results First Received: August 9, 2011
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
cystic fibrosis
mucociliary clearance
outcome measures

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013