Assessing Mucociliary Clearance and Airway Liquid Volume in the CF Airway
Pilot Study of a New Technique for Assessing Mucociliary Clearance and Airway Surface Liquid Volume in Cystic Fibrosis
1 other identifier
interventional
14
1 country
1
Brief Summary
The objective of this study is to determine the effect of airway surface liquid (ASL) volume on mucociliary clearance in cystic fibrosis (CF). A two-isotope nuclear medicine technique will be utilized. This pilot trial will include the imaging of n=7 CF subjects and n=7 healthy subjects. The trial will include one study visit per subject that will take approximately 3 hours. Hypothesis: The simultaneous imaging of both a "floating" and a "penetrating" radioisotope tag will allow the relative effect of airway surface liquid volume on mucociliary clearance to be determined when evaluated in CF and normal subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2005
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 2, 2005
CompletedFirst Posted
Study publicly available on registry
November 4, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedJuly 25, 2017
July 1, 2017
November 2, 2005
July 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
radioisotope clearance rates-comparison between healthy and cf subjects
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical symptoms (CF subjects only)
- Clinically stable as determined by the investigator (pulmonologist)
You may not qualify if:
- Reactive airways disease
- Tobacco smokers
- Positive urine pregnancy test on the day of testing
- FEV1p value of \< 30%
- SaO2 \< 92%, or if they require supplemental oxygen.
- Subjects receiving other radioisotope treatments within the last 2 weeks will be excluded.
- Normal subjects with any history of lung disease will be excluded.
- Women currently breastfeeding an infant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Cystic Fibrosis Foundationcollaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
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.
PMID: 19717485DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy E Corcoran, Ph.D.
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine and Bioengineering
Study Record Dates
First Submitted
November 2, 2005
First Posted
November 4, 2005
Study Start
November 1, 2005
Study Completion
August 1, 2006
Last Updated
July 25, 2017
Record last verified: 2017-07