Sodium Pyruvate Therapy in COPD Patients

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emphycorp
• Collaborators: Cellular Sciences; Cellular Sciences, inc.

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.