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Absorptive Clearance in the Cystic Fibrosis Airway

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ClinicalTrials.gov Identifier: NCT00541190
Recruitment Status : Completed
First Posted : October 10, 2007
Results First Posted : February 3, 2012
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Tim Corcoran, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE October 5, 2007
First Posted Date  ICMJE October 10, 2007
Results First Submitted Date  ICMJE August 9, 2011
Results First Posted Date  ICMJE February 3, 2012
Last Update Posted Date August 24, 2017
Study Start Date  ICMJE October 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2012)
Absorptive Clearance Rate [ Time Frame: single measurement ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
Absorptive Clearance Rate [ Time Frame: single measurement ]
Change History Complete list of historical versions of study NCT00541190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2012)
Mucociliary Clearance Rate [ Time Frame: single measurement ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
Mucociliary Clearance Rate [ Time Frame: single measurement ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Absorptive Clearance in the Cystic Fibrosis Airway
Official Title  ICMJE Absorptive Clearance in the Cystic Fibrosis Airway
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: cystic fibrosis
    Cystic fibrosis patients
    Intervention: Other: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA
  • Experimental: healthy controls
    Healthy control subjects
    Intervention: Other: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2012)
21
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2007)
24
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00541190
Other Study ID Numbers  ICMJE PRO07060240
NIH K25 HL081533-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Tim Corcoran, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy E Corcoran, Ph.D. University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP