Sodium Pyruvate Therapy in COPD Patients

NCT00262613 | Completed Phase 2

• 1 other identifier: CSI-NII5-021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Sodium Pyruvate; COPD; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Lung function, as determined by spirometry

• Safety, as determined by laboratory analyses

Secondary Outcomes (3)

• Levels of Nitric Oxide in expired air

• Results of Chronic Respiratory Disease Questionnaire

• SaO2 levels

Interventions

sodium pyruvate in 0.9% sodium chloride solution DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emphycorp: lead
• Cellular Sciences, inc.: collaborator

Study Sites (2)

Hospital for Special Care

New Britain, Connecticut, 06053, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520-8057, United States

Location

Related Links

• Emphycorp Website

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• John J. Votto, D.O.

  Hospital for Special Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 7, 2005
• Study Start: September 1, 2004
• Study Completion: May 1, 2006
• Last Updated: May 29, 2006

Record last verified: 2006-05

Locations

US (2)