drugset / Trial / NCT02947126

Multilevel Models of Therapeutic Response in the Lungs

NCT02947126

Non-randomizedCrossoverOpen-labelBasic science

Summary

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.

Timeline

Start
2017-01
Primary completion
2020-02
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Hypertonic saline Unknown 7 % Inhaled
Subject sodium chloride Unknown 0.9 % Inhaled
Background Indium-DTPA Unknown 55.5 mbq Inhaled
Background Technetium Sulfur Colloid Unknown 296 mbq Inhaled

Indications