Sodium Pyruvate Therapy in COPD Patients

This study has been completed.
Sponsor:
Collaborator:
Cellular Sciences
Information provided by:
Emphycorp
ClinicalTrials.gov Identifier:
NCT00262613
First received: December 6, 2005
Last updated: May 25, 2006
Last verified: May 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Long-Term Use of Inhaled Sodium Pyruvate for the Treatment of Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

Keywords provided by Emphycorp:
Sodium Pyruvate
COPD
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014