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

• Status: Terminated
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emphycorp

Criteria

Inclusion Criteria:

1. A physician diagnosis of asthma

2. Age years old

3. Symptoms consistent with asthma for at least 6 months

4. 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

5. FEV1 at screening 50-80% predicted (Hankinson6)

6. Reversibility with albuterol of 12% and 200 ml FEV1FEV1 at 30 minutes.

Exclusion Criteria:

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