Status:
COMPLETED
Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.
Lead Sponsor:
Emphycorp
Collaborating Sponsors:
Cellular Sciences, inc.
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Detailed Description
Cystic fibrosis (CF) is the most common, lethal inherited disease of Caucasians. Approximately 30,000 people in the United States and 70,000 worldwide have a diagnosis of CF. It is caused by mutations...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00308243
Start Date
March 1 2006
End Date
March 1 2007
Last Update
July 19 2011
Active Locations (1)
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1
University of Minnesota Medical School, The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, United States, 55455