Assessing Mucociliary Clearance and Airway Liquid Volume in the CF Airway

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. Identifier: NCT00248755
Recruitment Status : Completed
First Posted : November 4, 2005
Last Update Posted : July 25, 2017
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Tim Corcoran, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Procedure: mucociliary clearance scan Not Applicable

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  (Clinical Trial)
Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of a New Technique for Assessing Mucociliary Clearance and Airway Surface Liquid Volume in Cystic Fibrosis
Study Start Date : November 2005
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Primary Outcome Measures :
  1. radioisotope clearance rates-comparison between healthy and cf subjects

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00248755

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Cystic Fibrosis Foundation Therapeutics
Principal Investigator: Timothy E Corcoran, Ph.D. University of Pittsburgh

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tim Corcoran, Associate Professor of Medicine and Bioengineering, University of Pittsburgh Identifier: NCT00248755     History of Changes
Other Study ID Numbers: CFFR883
First Posted: November 4, 2005    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017

Keywords provided by Tim Corcoran, University of Pittsburgh:
cystic fibrosis
mucociliary clearance
nuclear medicine

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases