NCT00541190

Absorptive Clearance in the Cystic Fibrosis Airway

Completed NA Results posted Last updated 24 July 2017

What this trial tests

NA trial testing Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA in Cystic Fibrosis in 21 participants. Completed in 1 April 2008.

Timeline

1 October 2007

Primary endpoint
1 April 2008

1 April 2008

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	21
Start date	1 October 2007
Primary completion	1 April 2008
Estimated completion	1 April 2008
Sites	1 location across United States

Drugs / interventions tested

• Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

University of Pittsburgh

Who can join

18 and older, any sex, with Cystic Fibrosis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 DT

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
   Locke LW, Myerburg MM, Weiner DJ, Markovetz MR, et al · · 2016 · cited 22× · PMID 27009167 · DOI 10.1183/13993003.01880-2015
2. Absorptive clearance of DTPA as an aerosol-based biomarker in the cystic fibrosis airway.
   Corcoran TE, Thomas KM, Myerburg MM, Muthukrishnan A, et al · · 2010 · cited 14× · PMID 19717485 · DOI 10.1183/09031936.00059009
3. Multiprobe Nuclear Imaging of the Cystic Fibrosis Lung as a Biomarker of Therapeutic Effect.
   Corcoran TE, Huber AS, Myerburg MM, Weiner DJ, et al · · 2019 · cited 4× · PMID 30969149 · DOI 10.1089/jamp.2018.1491