Overview
A Phase I Study of Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.
Status:
Terminated
Terminated
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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 function, as determined by FEV1, or reduce inflammatory markers in induced sputum of people with CF.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of Minnesota
University of Minnesota - Clinical and Translational Science InstituteCollaborators:
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 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