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Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00308243
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : July 19, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
It is hypothesized that the inhalation of sodium pyruvate will reduce lung damage in patients with Cystic Fibrosis (CF) by its ability to reduce levels of toxic reactive oxygen and nitrogen compounds associated with the chronic inflammatory component of the disease. The primary objective of the study is to assess the safety of inhaled sodium pyruvate in 0.9% sodium chloride (saline) solution in people with CF. Further, to determine whether inhaled sodium pyruvate will improve lung function, as determined by spirometry, or reduced inflammatory markers in induced sputum of people with CF.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Sodium Pyruvate in 0.9% Sodium Chloride Solution Phase 1

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. Stage 1)
Study Start Date : March 2006
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. The primary outcome variable is the assessment of safety of inhaled sodium pyruvate in subjects with CF.

Secondary Outcome Measures :
  1. The secondary outcome variable is the determination of improvement in lungs of CF subjects as determined by measurement of FEV1 and/or as determined by measurement of reduced inflammatory markers in induced sputum.

Eligibility Criteria

Information from the National Library of Medicine

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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:

  • Clinical diagnosis of CF using Cystic Fibrosis Foundation criteria.
  • FEV1 >40% predicted
  • Colonization with Pseudomonas aeruginosa - (>= 2 positive cultures over past 12 months)
  • >18 years of age
  • Stable respiratory status without dyspnea
  • Non-smoker
  • Able to perform sputum induction

Exclusion Criteria:

  • Severe CF with an FEV1 of <40% predicted
  • Lung disease not CF related
  • Positive culture for Burkholderia cepacia
  • Active allergic bronchopulmonary aspergillosis
  • Clinically significant cardiac disease
  • Pregnancy
  • Females of child bearing age not using contraception
  • Females lactating
  • <18 years of age
  • Systemic steroid treatment within 1 month
  • Hospitalization within 3 months due to airway disease
  • Immunotherapy
  • Changes in respiratory medication use within 1 month
  • New medications within 1 month
  • Participation in research study within 1 month
  • History of significant (>60 cc) hemoptysis within 1 year
  • Poorly controlled insulin dependent diabetes mellitus
  • Acute respiratory illness within 1 month
  • Use of tobacco products or recreational drugs
  • History of adverse reaction to sputum induction
Contacts and Locations

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): NCT00308243


Locations
United States, Minnesota
University of Minnesota Medical School, The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Emphycorp
Cellular Sciences
Investigators
Study Director: Joanne Billings, MD University of Minnesota; Pulmonary, Allergy & Critical Care Medicine
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00308243     History of Changes
Other Study ID Numbers: CSI-N115-I-010-01
Orphan Drug 02-1656
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

Keywords provided by Emphycorp:
Cystic Fibrosis
Sodium Pyruvate
Reactive Oxygen Species
Inflammation of Lung

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases