Sodium Pyruvate Therapy in COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00262613
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : May 29, 2006
Cellular Sciences
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: sodium pyruvate in 0.9% sodium chloride solution Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Long-Term Use of Inhaled Sodium Pyruvate for the Treatment of Chronic Obstructive Pulmonary Disease
Study Start Date : September 2004
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Primary Outcome Measures :
  1. Lung function, as determined by spirometry
  2. Safety, as determined by laboratory analyses

Secondary Outcome Measures :
  1. Levels of Nitric Oxide in expired air
  2. Results of Chronic Respiratory Disease Questionnaire
  3. SaO2 levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00262613

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
Cellular Sciences
Principal Investigator: John J. Votto, D.O. Hospital for Special Care

Additional Information: Identifier: NCT00262613     History of Changes
Other Study ID Numbers: CSI-NII5-021
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: May 29, 2006
Last Verified: May 2006

Keywords provided by Emphycorp:
Sodium Pyruvate
Chronic Obstructive Pulmonary Disease

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