Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.

This study is currently recruiting participants.

Verified by Emphycorp, September 2006

First Received: March 27, 2006 Last Updated: September 21, 2006 History of Changes

Sponsors and Collaborators:	Emphycorp Cellular Sciences
Information provided by:	Emphycorp
ClinicalTrials.gov Identifier:	NCT00308243

Purpose

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.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: Sodium Pyruvate in 0.9% Sodium Chloride Solution	Phase I

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. Stage 1)

Further study details as provided by Emphycorp:

Primary Outcome Measures:

The primary outcome variable is the assessment of safety of inhaled sodium pyruvate in subjects with CF.

Secondary Outcome Measures:

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.

Estimated Enrollment:	15
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of CF using Cystic Fibrosis Foundation criteria.
FEV1 >40% predicted
Colonization with Pseudomonas aeruginosa – (>= 2 positive cultures over past 12 months)
>18 years of age
Stable respiratory status without dyspnea
Non-smoker
Able to perform sputum induction

Exclusion Criteria:

Severe CF with an FEV1 of <40% predicted
Lung disease not CF related
Positive culture for Burkholderia cepacia
Active allergic bronchopulmonary aspergillosis
Clinically significant cardiac disease
Pregnancy
Females of child bearing age not using contraception
Females lactating
<18 years of age
Systemic steroid treatment within 1 month
Hospitalization within 3 months due to airway disease
Immunotherapy
Changes in respiratory medication use within 1 month
New medications within 1 month
Participation in research study within 1 month
History of significant (>60 cc) hemoptysis within 1 year
Poorly controlled insulin dependent diabetes mellitus
Acute respiratory illness within 1 month
Use of tobacco products or recreational drugs
History of adverse reaction to sputum induction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308243

Contacts

Contact: Carlos E Milla, MD	612.626.2916	milla005@umn.edu
Contact: Brooke Noren, RN	612.625.7995	boer001@umn.edu

Locations

United States, Minnesota
University of Minnesota Medical School, The Minnesota Cystic Fibrosis Center	Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Carlos E Milla, MD

Sponsors and Collaborators

Emphycorp

Cellular Sciences

Investigators

Study Director:

Joanne Billings, MD

University of Minnesota; Pulmonary, Allergy & Critical Care Medicine

More Information

Additional Information:

Click here for more information about this study: Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. (Stage 1) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CSI-N115-I-010-01, Orphan Drug 02-1656
Study First Received:	March 27, 2006
Last Updated:	September 21, 2006
ClinicalTrials.gov Identifier:	NCT00308243 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emphycorp:

Cystic Fibrosis
Sodium Pyruvate
Reactive Oxygen Species
Inflammation of Lung

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 06, 2009