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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
Results First Received: August 9, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Cystic Fibrosis
Intervention: Other: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Cystic fibrosis subjects were recruited during normal clinical visits. Healthy control subjects were recruited using posted advertisement.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled subjects performed a single nuclear medicine imaging study.

Reporting Groups
  Description
Cystic Fibrosis Cystic fibrosis patients
Healthy Controls Healthy subjects.

Participant Flow:   Overall Study
    Cystic Fibrosis     Healthy Controls  
STARTED     10     11  
COMPLETED     10     11  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Cystic Fibrosis Cystic fibrosis patients
Healthy Controls Healthy subjects.
Total Total of all reporting groups

Baseline Measures
    Cystic Fibrosis     Healthy Controls     Total  
Number of Participants  
[units: participants]
 		  10     11     21  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     10     11     21  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  29  ± 11     29  ± 7     29  ± 9  
Gender  
[units: participants]
 		     
Female     3     5     8  
Male     7     6     13  
Region of Enrollment  
[units: participants]
 		     
United States     10     11     21  



  Outcome Measures
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1.  Primary:   Absorptive Clearance Rate   [ Time Frame: single measurement ]
  Show Outcome Measure 1

2.  Secondary:   Mucociliary Clearance Rate   [ Time Frame: single measurement ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Tim Corcoran
Organization: University of Pittsburgh
phone: 412-624-8918
e-mail: corcorante@upmc.edu


No publications provided by University of Pittsburgh

Publications automatically indexed to this study:


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