Status:
COMPLETED
Sodium Pyruvate Therapy in COPD Patients
Lead Sponsor:
Emphycorp
Collaborating Sponsors:
Cellular Sciences, inc.
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 k...
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a disease, which involves the conducting airways of the respiratory tract and affects 5-10% of individuals in the United States. The morbidity and morta...
Eligibility Criteria
Inclusion
- Individuals with a clinical diagnosis of moderate to severe COPD, \<70% predicted FEV1, and a stable pulmonary disease status.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00262613
Start Date
September 1 2004
End Date
May 1 2006
Last Update
May 29 2006
Active Locations (2)
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1
Hospital for Special Care
New Britain, Connecticut, United States, 06053
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8057