Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.
It is hypothesized that the inhalation of sodium pyruvate will reduce lung damage in patients with Cystic Fibrosis (CF) by its ability to reduce levels of toxic reactive oxygen and nitrogen compounds associated with the chronic inflammatory component of the disease. The primary objective of the study is to assess the safety of inhaled sodium pyruvate in 0.9% sodium chloride (saline) solution in people with CF. Further, to determine whether inhaled sodium pyruvate will improve lung function, as determined by spirometry, or reduced inflammatory markers in induced sputum of people with CF.
Drug: Sodium Pyruvate in 0.9% Sodium Chloride Solution
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. Stage 1)|
- 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.
|Study Start Date:||March 2006|
|Study Completion Date:||March 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
|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|