Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.
|ClinicalTrials.gov Identifier: NCT00308243|
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : July 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Sodium Pyruvate in 0.9% Sodium Chloride Solution||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. Stage 1)|
|Study Start Date :||March 2006|
|Primary Completion Date :||March 2007|
|Study Completion Date :||March 2007|
U.S. FDA Resources
- The primary outcome variable is the assessment of safety of inhaled sodium pyruvate in subjects with CF.
- The secondary outcome variable is the determination of improvement in lungs of CF subjects as determined by measurement of FEV1 and/or as determined by measurement of reduced inflammatory markers in induced sputum.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308243
|United States, Minnesota|
|University of Minnesota Medical School, The Minnesota Cystic Fibrosis Center|
|Minneapolis, Minnesota, United States, 55455|
|Study Director:||Joanne Billings, MD||University of Minnesota; Pulmonary, Allergy & Critical Care Medicine|