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

This study has been terminated.
(Patients did not respond to therapy)
Sponsor:
Information provided by:
Emphycorp
ClinicalTrials.gov Identifier:
NCT00262652
First received: December 6, 2005
Last updated: June 24, 2011
Last verified: November 2005
  Purpose

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 Intervention Phase
Moderate Asthma
Drug: sodium pyruvate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sodium Pyruvate Bronchodilation in Asthmatics

Resource links provided by NLM:


Further study details as provided by Emphycorp:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • No other primary outcome variable [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: December 6, 2005
Last Updated: June 24, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014