Sodium Pyruvate Therapy in COPD Patients - Full Text View

Sponsors and Collaborators:	Emphycorp Cellular Sciences
Information provided by:	Emphycorp
ClinicalTrials.gov Identifier:	NCT00262613

Purpose

In animal models, sodium pyruvate has been shown to be an effective anti-inflammatory agent, and in human studies sodium pyruvate has been shown to be a bronchodilating agent. Subjects with COPD are known to have inflammation in the lung, and often have bronchoconstriction. As such, these subjects typically are on multiple therapies, including steroid therapy. This trial will study the effect of inhaled sodium pyruvate on inflammation and lung function in COPD subjects over a six week period.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: sodium pyruvate in 0.9% sodium chloride solution	Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Sodium chloride Chlorides

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Long-Term Use of Inhaled Sodium Pyruvate for the Treatment of Chronic Obstructive Pulmonary Disease

Further study details as provided by Emphycorp:

Primary Outcome Measures:

Lung function, as determined by spirometry
Safety, as determined by laboratory analyses

Secondary Outcome Measures:

Levels of Nitric Oxide in expired air
Results of Chronic Respiratory Disease Questionnaire
SaO2 levels

Estimated Enrollment:	60
Study Start Date:	September 2004
Estimated Study Completion Date:	May 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Individuals with a clinical diagnosis of moderate to severe COPD, <70% predicted FEV1, and a stable pulmonary disease status.

Exclusion Criteria:

a. Pulmonary disease other than COPD
b. Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina
c. Pregnancy
d. Females of child bearing potential age not on adequate contraception or lactating
e. Subjects receiving oral or IV corticosteroid treatment within one month of Screening Visit
f. Less than 18 years of age and greater than 85 years of age
g. Hospitalization within last 6 months due to acute exacerbation of air-way disease
h. Subjects on escalating dose of immunotherapy
i. Subjects with a clinically significant abnormal chest x-ray within past 12 months.
j. Medication changes within 1 month
k. Subjects who have participated in another investigation drug treatment study within the previous month.
l. Subjects with a current history of alcohol abuse or recreational drug use.
m. Subjects who have taken vitamins with anti-oxidant properties (E or C) or dietary supplements containing pyruvate within 24 hours prior to the screening visit.
n. Subjects who use less than 4 puffs of Albuterol a day over the period between the Screening Visit and Visit 1.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262613

Locations

United States, Connecticut
Hospital for Special Care
New Britain, Connecticut, United States, 06053
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8057

Sponsors and Collaborators

Emphycorp

Cellular Sciences

Investigators

Principal Investigator:

John J. Votto, D.O.

Hospital for Special Care

More Information

Emphycorp Website This link exits the ClinicalTrials.gov site

Study ID Numbers:	CSI-NII5-021
Study First Received:	December 6, 2005
Last Updated:	May 25, 2006
ClinicalTrials.gov Identifier:	NCT00262613
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emphycorp:

Sodium Pyruvate
COPD
Chronic Obstructive Pulmonary Disease

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009