Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248755
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2005-11-02
Brief Title:
Assessing Mucociliary Clearance and Airway Liquid Volume in the CF Airway
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Pilot Study of a New Technique for Assessing Mucociliary Clearance and Airway Surface Liquid Volume in Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n7 CF subjects and n7 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
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 n5 CF subjects and n5 healthy subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None