Sodium Pyruvate Therapy in COPD Patients
This study has been completed.
Sponsor:
Emphycorp
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
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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
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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 17, 2013