drugset / Trial / NCT00628134

Self-dispersing Liquids as Aerosol Drug Carriers

NCT00628134 ↗

RandomizedCrossoverSingle-blindBasic science

Summary

Inhaled medications are often used to treat lung diseases such as cystic fibrosis. We are performing this study to determine whether inhaled medications dissolved in surfactant-based solutions will distribute more evenly throughout the lungs when compared to standard saline-based solutions. We think that inhaling medication that is in a surfactant-based liquid will result in more medication reaching partially blocked parts of the lung. This study will use a special nuclear medicine test called an aerosol deposition scan to compare how a drug spreads in the lung using a surfactant-based aerosol compared to a saline-based aerosol.

Timeline

Start
2008-03
Primary completion
2009-08
Completion
2009-08

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Subjects Inhaling Saline vs Subjects Inhaling Surfactant; p = 0.07; Wilcoxon (Mann-Whitney) NCT00628134 ↗

paper Our results lack statistical significance PMID 22393908 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Calfactant Protein / enzyme biologic — Inhaled

Indications