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Safety and Efficacy Study of the Use of Sodium Pyruvate Bronchodilation in Asthmatics

NCT00262652 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-06-27

No results posted yet for this study

Summary

Sodium pyruvate in sodium chloride solution will be delivered by nebulization to the lungs. It is believed that this administration will produce bronchodilation in asthmatics as determined by improvement in FEV1. FEV1 is a measure of lung function, and will be determined after administration of sodium pyruvate. The study is a blinded, so subjects may receive either the sodium pyruvate or a sodium chloride placebo. The primary endpoint will be the improvement of FEV1 after 15 minutes in subjects receiving sodium pyruvate compared to the FEV1 of subjects receiving the sodium chloride placebo.

Conditions

  • Moderate Asthma

Interventions

DRUG

sodium pyruvate

Sponsors & Collaborators

  • Emphycorp

    lead INDUSTRY

Principal Investigators

  • Donald Tashkin, M.D. · University of California, Los Angeles; Center for the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2006-09-30
Completion
2006-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00262652 on ClinicalTrials.gov