Safety and Efficacy Study of the Use of Sodium Pyruvate Bronchodilation in Asthmatics
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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 |
- 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 |
Inclusion Criteria:
- 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 Criteria:
-
Contacts and Locations| United States, California | |
| David Geffen School of Medicine, UCLA | |
| Los Angeles, California, United States, 90095 | |
| 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 |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013