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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Cystic Fibrosis
Intervention Other: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA
Enrollment 21
Recruitment Details Cystic fibrosis subjects were recruited during normal clinical visits. Healthy control subjects were recruited using posted advertisement.
Pre-assignment Details All enrolled subjects performed a single nuclear medicine imaging study.
Arm/Group Title Cystic Fibrosis Healthy Controls
Hide Arm/Group Description Cystic fibrosis patients Healthy subjects.
Period Title: Overall Study
Started 10 11
Completed 10 11
Not Completed 0 0
Arm/Group Title Cystic Fibrosis Healthy Controls Total
Hide Arm/Group Description Cystic fibrosis patients Healthy subjects. Total of all reporting groups
Overall Number of Baseline Participants 10 11 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
11
 100.0%
21
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 11 participants 21 participants
29  (11) 29  (7) 29  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
Female
3
  30.0%
5
  45.5%
8
  38.1%
Male
7
  70.0%
6
  54.5%
13
  61.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 11 participants 21 participants
10 11 21
1.Primary Outcome
Title Absorptive Clearance Rate
Hide Description 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.
Time Frame single measurement
Hide Outcome Measure Data
Hide Analysis Population Description
No formal power analysis was performed for this pilot study. Two subjects (one CF, one control) were identified as obvious outliers with whole lung Tc-SC clearance rates more than two standard deviations above the average of the group. These outliers were excluded from further analyses.
Arm/Group Title Cystic Fibrosis Healthy Controls
Hide Arm/Group Description:
Cystic fibrosis patients - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
Healthy subjects without lung disease - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: percentage of DTPA absoprtion per hour
42  (11) 32  (7)
2.Secondary Outcome
Title Mucociliary Clearance Rate
Hide Description 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.
Time Frame single measurement
Hide Outcome Measure Data
Hide Analysis Population Description
No formal power analysis was performed for this pilot study. Two subjects (one CF, one control) were identified as obvious outliers with whole lung Tc-SC clearance rates more than two standard deviations above the average of the group. These outliers were excluded from further analyses.
Arm/Group Title Cystic Fibrosis Healthy Controls
Hide Arm/Group Description:
Cystic fibrosis patients
Healthy subjects.
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: percentage lung clearance per hour
8  (4) 7  (4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cystic Fibrosis Healthy Controls
Hide Arm/Group Description Cystic fibrosis patients Healthy subjects.
All-Cause Mortality
Cystic Fibrosis Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cystic Fibrosis Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cystic Fibrosis Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tim Corcoran
Organization: University of Pittsburgh
Phone: 412-624-8918
EMail: corcorante@upmc.edu
Layout table for additonal information
Responsible Party: Tim Corcoran, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00541190     History of Changes
Other Study ID Numbers: PRO07060240
NIH K25 HL081533-02
First Submitted: October 5, 2007
First Posted: October 10, 2007
Results First Submitted: August 9, 2011
Results First Posted: February 3, 2012
Last Update Posted: August 24, 2017