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

NCT00332215 | Terminated Phase 1

• 2 other identifiers: 0511M77511CSI-N115-I-010-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 function, as determined by FEV1, or reduce inflammatory markers in induced sputum of people with CF.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Antioxidants; Inhalational therapy; Induced sputum; Airway inflammation

Outcome Measures

Primary Outcomes (1)

• The primary outcome variable is the assessment of safety of inhaled sodium pyruvate in subjects with CF.Subjects will be evaluated for the presence of symptoms and safety laboratory measurements.

Secondary Outcomes (1)

• The secondary outcome variable is the determination of improvement in lungs of CF subjects as determined by measurement of FEV1 and measurement of inflammatory markers in induced sputum.

Interventions

Inhaled Sodium Pyruvate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of Minnesota: lead
• Cellular Sciences, inc.: collaborator

Study Sites (1)

University of Minnesota General Clinical Research Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

• O'Donnell-Tormey J, Nathan CF, Lanks K, DeBoer CJ, de la Harpe J. Secretion of pyruvate. An antioxidant defense of mammalian cells. J Exp Med. 1987 Feb 1;165(2):500-14. doi: 10.1084/jem.165.2.500.

  PMID: 3102672 BACKGROUND

• Votto J, Bowen J, Metersky M, Thrall R. Effect of Inhaled Sodium Pyruvate in Patients with Mild Bronchial Asthma. Am J Resp Crit Care Med 2001, 163 (5S):A860.

  BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Carlos E Milla, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Joanne L Billings, MD, MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: June 1, 2006
• Study Start: February 1, 2006
• Last Updated: December 1, 2008

Record last verified: 2008-11

Locations

US (1)