Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emphycorp
• Collaborators: Cellular Sciences; Cellular Sciences, inc.

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