- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00248755
Assessing Mucociliary Clearance and Airway Liquid Volume in the CF Airway
July 24, 2017 updated by: Tim Corcoran, University of Pittsburgh
Pilot Study of a New Technique for Assessing Mucociliary Clearance and Airway Surface Liquid Volume in Cystic Fibrosis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Improper function of the mucociliary clearance system in the Cystic Fibrosis (CF) lung is a major factor contributing to the chronic respiratory manifestations of the disease.
Normally this host defense mechanism removes inhaled pathogens and toxins from the inner surfaces of the lung.
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 the liquid lining the airways becomes very thin and viscous due to abnormal absorption of sodium from the airways, which draws water out of the airways, partially or totally defeating mucociliary clearance.
The rate at which the mucociliary system clears materials from the lungs can be quantified using a nuclear medicine test called a mucociliary clearance scan.
This study pilots a new variation of the mucociliary clearance scan that uses both "floating" and "penetrating" radioisotope tags.
The difference in clearance between these tags will provide information on how airway surface liquid volume affects mucociliary clearance.
This pilot trial will include the imaging of n=5 CF subjects and n=5 healthy subjects.
Study Type
Interventional
Enrollment
14
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:
- 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)
Exclusion Criteria:
- 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.
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: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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radioisotope clearance rates-comparison between healthy and cf subjects
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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
November 1, 2005
Study Completion (ACTUAL)
August 1, 2006
Study Registration Dates
First Submitted
November 2, 2005
First Submitted That Met QC Criteria
November 2, 2005
First Posted (ESTIMATE)
November 4, 2005
Study Record Updates
Last Update Posted (ACTUAL)
July 25, 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
- CFFR883
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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