NCT02947126

Multilevel Models of Therapeutic Response in the Lungs

Completed Phase 1 Last updated 11 January 2023

What this trial tests

Phase 1 trial testing Hypertonic Saline in Cystic Fibrosis in 56 participants. Completed in 1 December 2022.

Timeline

1 January 2017

Primary endpoint
1 February 2020

1 December 2022

Quick facts

Lead sponsor	Tim Corcoran
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	56
Start date	1 January 2017
Primary completion	1 February 2020
Estimated completion	1 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Hypertonic Saline — full drug profile →
• Isotonic Saline — full drug profile →
• Indium-DTPA — full drug profile →
• Technetium Sulfur Colloid — full drug profile →

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Tim Corcoran — full company profile →

Who can join

12 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.

• Mucociliary Clearance
  Time frame: 80 minutes
  Clearance rate of Technetium sulfur colloid from the lungs
• DTPA absorption rate
  Time frame: 80 minutes
  DTPA absorption rate from the lungs (difference between total In-DTPA clearance rate and mucociliary clearance rate)

Sponsor's own description

When developing new medications for lung diseases like Cystic Fibrosis (CF), scientists perform lab experiments using cells from the airways, physiology studies of how the lungs change when a drug is given, and clinical studies to determine how drugs affect overall health. The investigators of this study are seeking to develop computer models that will predict how patients will respond to drugs by just doing lab studies on cell samples from their noses. Such models would allow for medications to be developed more rapidly for all patients and allow treatments to be personalized as well. In order to develop these computer models a series of tests will be performed on patients who have CF. Tests will include sampling cells from the nose and measuring lung physiology using a combination of different imaging, breathing, and other studies performed both before and after participants take a therapy. Similar tests will be performed on people who do not have CF, and on the parents of the CF participants who carry a single CF gene because this will provide information on how specific genes might affect CF lung disease.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nasal epithelial cell culture fluorescence recovery after photobleaching predicts cystic fibrosis therapeutic response.
   Corcoran TE, Bertrand CA, Myerburg MM, Weiner DJ, et al · · 2022 · cited 2× · PMID 36655223 · DOI 10.1183/23120541.00382-2022