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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00308243
Date of registration: 27/03/2006
Prospective Registration: Yes
Primary sponsor: Emphycorp
Public title: Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.
Scientific title: Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. Stage 1)
Date of first enrolment: March 2006
Target sample size: 15
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00308243
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Joanne Billings, MD
Address: 
Telephone:
Email:
Affiliation:  University of Minnesota; Pulmonary, Allergy & Critical Care Medicine
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Intervention(s)
Drug: Sodium Pyruvate in 0.9% Sodium Chloride Solution
Primary Outcome(s)
The primary outcome variable is the assessment of safety of inhaled sodium pyruvate in subjects with CF.
Secondary Outcome(s)
The secondary outcome variable is the determination of improvement in lungs of CF subjects as determined by measurement of FEV1 and/or as determined by measurement of reduced inflammatory markers in induced sputum.
Secondary ID(s)
CSI-N115-I-010-01
Orphan Drug 02-1656
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Cellular Sciences
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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