A Phase I Study of Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.

This study has been terminated.
(Dr. Milla has left University of Minnesota. The study is no longer being conducted at this site.)
Sponsor:
Collaborator:
Cellular Sciences
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00332215
First received: May 30, 2006
Last updated: November 26, 2008
Last verified: November 2008
  Purpose

The primary objective of this study is to assess the safety of inhaled sodium pyruvate in people with Cystic Fibrosis (CF). Further, to determine whether inhaled sodium pyruvate will improve lung function, as determined by FEV1, or reduce inflammatory markers in induced sputum of people with CF.


Condition Intervention Phase
Cystic Fibrosis
Drug: Inhaled Sodium Pyruvate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study.

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • The primary outcome variable is the assessment of safety of inhaled sodium pyruvate in subjects with CF.Subjects will be evaluated for the presence of symptoms and safety laboratory measurements.

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

Estimated Enrollment: 70
Study Start Date: February 2006
Detailed Description:

Cystic fibrosis (CF) is a disease that causes airway blockage and infection that damages the lung. The lungs of CF patients are frequently loaded with inflammatory cells, damaging proteins and oxidants. Oxidants are molecules that contain oxygen and are capable of disrupting cells and tissue. The CF protein is involved in the transport of the important antioxidant glutathione (GSH). Antioxidants are molecules that block oxidants and render them inactive. The absence of this protection in the airways makes them prone to damage from oxidants. Sodium pyruvate is part of the body's natural anti-oxidant defense system. Sodium pyruvate reacts directly with oxygen radicals to neutralize them and increases cellular levels of glutathione.

The purpose of this study is to investigate the safety and tolerability of 3 different single dose levels of sodium pyruvate administered via a nebulizer to persons with CF lung disease.

This will be a phase I study with 3 stages. In the first stage subjects will receive one of 3 possible doses of the active drug only once. In the second stage subjects will receive 2 doses of the active drug 12 hours apart. In the third stage subjects will receive either active drug or placebo every 12 hours for 4 weeks.

For stage 1 subjects will come to the University of Minnesota's General Clinical Research Center (GCRC) for a screening visit. They will return to the GCRC 1 to 7 days later for a baseline assessment that will be followed by study drug administration. The subject will be observed for 4 hours and safety parameters will be obtained.

For stage 2 subjects will come to the GCRC for a screening visit. They will return to the GCRC 1 to 7 days later for a baseline assessment that will be followed by study drug administration. Safety parameters will be obtained for the following 4 hours. 12 hours after the first dose was given the subject will receive a second dose and safety parameters will again be obtained over the next 4 hours.

For stage 3 subjects will come to the GCRC for a screening visit. They will return to the GCRC 1 to 7 days later for a baseline assessment that will be followed by study drug administration. Safety parameters will be obtained for the following 4 hours. The subject will be sent home to continue on study drug every 12 hours for the following 4 weeks. The subject will be asked to return to the GCRC once a week for safety assessments.

  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 at rest
  • Non-smoker
  • Able to perform sputum induction

Exclusion Criteria:

  • Severe CF lung disease with an FEV1 of <40% predicted
  • Lung disease not CF related
  • Positive culture for Burkholderia cepacia over previous 2 years
  • 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
  • Administration of any investigational drug or device within 28 days of visit 1 or within 6 half-lives of the investigational drug (whichever is longer).
  • 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: NCT00332215

Locations
United States, Minnesota
University of Minnesota General Clinical Research Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Cellular Sciences
Investigators
Principal Investigator: Carlos E Milla, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Joanne L Billings, MD, MPH University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Votto J, Bowen J, Metersky M, Thrall R. Effect of Inhaled Sodium Pyruvate in Patients with Mild Bronchial Asthma. Am J Resp Crit Care Med 2001, 163 (5S):A860.

ClinicalTrials.gov Identifier: NCT00332215     History of Changes
Other Study ID Numbers: 0511M77511, CSI-N115-I-010-01
Study First Received: May 30, 2006
Last Updated: November 26, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Cystic Fibrosis
Antioxidants
Inhalational therapy
Induced sputum
Airway inflammation

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

ClinicalTrials.gov processed this record on October 01, 2014