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

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ClinicalTrials.gov Identifier: NCT00262652
Recruitment Status : Terminated (Patients did not respond to therapy)
First Posted : December 7, 2005
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Emphycorp

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.

Condition or disease Intervention/treatment Phase
Moderate Asthma Drug: sodium pyruvate Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sodium Pyruvate Bronchodilation in Asthmatics
Study Start Date : January 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources




Primary Outcome Measures :
  1. 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. [ Time Frame: Four Hour Testing ]
  2. No other primary outcome variable


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262652


Locations
United States, California
David Geffen School of Medicine, UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Emphycorp
Investigators
Principal Investigator: Donald Tashkin, M.D. University of California, Los Angeles; Center for the Health Sciences

Additional Information:
Responsible Party: Donald P. Tashkin, M.D., Professor of Medicine, David Geffen School of Medicine, UCLA
ClinicalTrials.gov Identifier: NCT00262652     History of Changes
Other Study ID Numbers: CSI-UCLA-ASTHMA-01
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: November 2005

Keywords provided by Emphycorp:
sodium pyruvate
anti-inflammatory
bronchodilation
asthma
asthmatics

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases