- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00541190
Absorptive Clearance in the Cystic Fibrosis Airway
July 24, 2017 updated by: Tim Corcoran, University of Pittsburgh
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cystic fibrosis
Cystic fibrosis patients
|
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
|
Subjects perform a single nuclear medicine scan after inhaling an aerosol containing Technetium 99m sulfur colloid and Indium 111 DTPA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
single measurement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
single measurement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Locke LW, Myerburg MM, Weiner DJ, Markovetz MR, Parker RS, Muthukrishnan A, Weber L, Czachowski MR, Lacy RT, Pilewski JM, Corcoran TE. Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung. Eur Respir J. 2016 May;47(5):1392-401. doi: 10.1183/13993003.01880-2015. Epub 2016 Mar 23.
- Corcoran TE, Thomas KM, Myerburg MM, Muthukrishnan A, Weber L, Frizzell R, Pilewski JM. Absorptive clearance of DTPA as an aerosol-based biomarker in the cystic fibrosis airway. Eur Respir J. 2010 Apr;35(4):781-6. doi: 10.1183/09031936.00059009. Epub 2009 Aug 28.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
October 5, 2007
First Submitted That Met QC Criteria
October 9, 2007
First Posted (Estimate)
October 10, 2007
Study Record Updates
Last Update Posted (Actual)
August 24, 2017
Last Update Submitted That Met QC Criteria
July 24, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO07060240
- NIH K25 HL081533-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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