A Phase I Study of Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.

Stopped early · Phase 1

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00332215

Run by

University of Minnesota

People needed

70

Starts

2006-02-01

Last updated by the study team

2008-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Minnesota General Clinical Research Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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