Status:
TERMINATED
Safety and Efficacy Study of the Use of Sodium Pyruvate Bronchodilation in Asthmatics
Lead Sponsor:
Emphycorp
Conditions:
Moderate Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 improvem...
Detailed Description
Sodium Pyruvate, an intermediate metabolite, has been investigated as a therapeutic agent to reduce reactive oxygen species in the lung. Evaluation of FEV1 as a safety parameter and sequela of reactiv...
Eligibility Criteria
Inclusion
- A physician diagnosis of asthma
- Age years old
- Symptoms consistent with asthma for at least 6 months
- Current asthma medications: Short-acting inhaled beta agonists as needed for control of asthma symptoms with or without a low to medium dose of an ICS, as defined in the table below and if on a ICS may also be on a long-acting beta agonist provided it is withheld for 24 hours prior to the testing days.
- Inhaled Corticosteroid Dose less than or equal to:
- Beclomethasone-HFA 480 µg/day Budesonide-DPI 1000 µg/day Flunisolide 2000 µg/day Fluticasone 500 µg/day Triamcinolone 2000 µg/day
- FEV1 at screening 50-80% predicted (Hankinson6)
- Reversibility with albuterol of 12% and 200 ml FEV1FEV1 at 30 minutes.
Exclusion
- \-
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00262652
Start Date
January 1 2006
End Date
September 1 2006
Last Update
June 27 2011
Active Locations (1)
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1
David Geffen School of Medicine, UCLA
Los Angeles, California, United States, 90095