Status:
TERMINATED
A Phase I Study of Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Cellular Sciences, inc.
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 func...
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 oxidant...
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 at rest
- Non-smoker
- Able to perform sputum induction
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00332215
Start Date
February 1 2006
Last Update
December 1 2008
Active Locations (1)
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1
University of Minnesota General Clinical Research Center
Minneapolis, Minnesota, United States, 55455