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

NCT00262652 | Terminated Phase 1 DMC

• 1 other identifier: CSI-UCLA-ASTHMA-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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

Keywords

sodium pyruvate; anti-inflammatory; bronchodilation; asthma; asthmatics

Outcome Measures

Primary Outcomes (2)

• ANCOVA using multiple measures evaluating FEV1% predicted at 5, 15, 30, 60, 120 and 240 minutes between saline and Sodium Pyruvate,and at 5, 15 and 30 minutes between albuterol and Sodium Pyruvate with the visit baseline FEV1% predicted as covariate.

  Four Hour Testing

• No other primary outcome variable

Interventions

sodium pyruvate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Emphycorp: lead

Study Sites (1)

David Geffen School of Medicine, UCLA

Los Angeles, California, 90095, United States

Location

Related Links

• Company Website

MeSH Terms

Conditions

Asthma

Interventions

BASS2 protein, Arabidopsis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Donald Tashkin, M.D.

  University of California, Los Angeles; Center for the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 7, 2005
• Study Start: January 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: June 27, 2011

Record last verified: 2005-11

Locations

US (1)