Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.

This study has been completed.
Sponsor:
Collaborator:
Cellular Sciences
Information provided by:
Emphycorp
ClinicalTrials.gov Identifier:
NCT00308243
First received: March 27, 2006
Last updated: July 17, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Cystic Fibrosis
Drug: Sodium Pyruvate in 0.9% Sodium Chloride Solution
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Emphycorp:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 15
Study Start Date: March 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (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:

  • 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
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: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00308243     History of Changes
Other Study ID Numbers: CSI-N115-I-010-01, Orphan Drug 02-1656
Study First Received: March 27, 2006
Last Updated: July 17, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 29, 2014