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Imaging Airway Liquid Absorption in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01486199
Recruitment Status : Completed
First Posted : December 6, 2011
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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: Absorptive clearance scan

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CF Pediatric Cystic Fibrosis subjects ages 6-14
Controls Adult Adult control subjects 18 or older

Participant Flow for 3 periods

Period 1:   Baseline Study Day
    CF Pediatric   Controls Adult
STARTED   10   10 
COMPLETED   10   9 
NOT COMPLETED   0   1 

Period 2:   Two Year Period Between Study Days
    CF Pediatric   Controls Adult
STARTED   10   0 
COMPLETED   9   0 
NOT COMPLETED   1   0 
Physician Decision                1                0 

Period 3:   Study Day at t= 2 Years
    CF Pediatric   Controls Adult
STARTED   9   0 
COMPLETED   9   0 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CF Pediatric Cystic Fibrosis subjects ages 6-14
Controls Adult Adult control subjects 18 or older
Total Total of all reporting groups

Baseline Measures
   CF Pediatric   Controls Adult   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 10.5  (1.5)   31.2  (15.0)   20.9  (14.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  50.0%      4  40.0%      9  45.0% 
Male      5  50.0%      6  60.0%      11  55.0% 


  Outcome Measures

1.  Primary:   Absorptive Clearance Rate   [ Time Frame: study day 1 ]

2.  Primary:   Mucociliary Clearance Rate   [ Time Frame: study day 1 ]

3.  Secondary:   Absorptive Clearance Rate   [ Time Frame: t=2 years ]

4.  Secondary:   Mucociliary Clearance Rate   [ Time Frame: t=2 years, measure made 80 minutes after radiopharmaceutical inhalation ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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


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

Responsible Party: Tim Corcoran, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01486199     History of Changes
Other Study ID Numbers: 1R01HL108929-01 ( U.S. NIH Grant/Contract )
R01HL108929 ( U.S. NIH Grant/Contract )
First Submitted: November 18, 2011
First Posted: December 6, 2011
Results First Submitted: April 5, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017