Inhaled Xylitol Versus Saline in Stable Subjects With Cystic Fibrosis

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt concentration has been shown to increase activity of salt sensitive antimicrobial peptides.

Xylitol is a 5-carbon sugar that can lower the ASL salt concentration, thus enhancing innate immunity.In this study, the investigators plan to study the safety and efficacy of 2 weeks of inhaled xylitol compared to 2 weeks of hypertonic saline in a randomized crossover design in stable subjects with cystic fibrosis

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph Zabner; University of Iowa
• Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago; Northwestern University

Criteria

Inclusion Criteria:

• Documented diagnosis of CF (medical record evidence of 2 identified CFTR(Cystic fibrosis transmembrane conductance regulator) mutations or a positive sweat chloride test or nasal voltage difference, and 1 or more clinical findings of CF)

• Age 16 or greater

• FEV1>30% predicted

• Oxygen saturation > or equal too 90% on room air

• Clinically stable, without evidence of pulmona4ry exacerbation for at least 2 weeks prior to screening (defined as use of oral or intravenous antibiotics for cystic fibrosis exacerbation)

• Use of effective contraception in women

• Ability to provide written informed consent and assent

• Successful completion of the trial doses of study drugs

Exclusion Criteria:

• Pregnancy

• Hemoptysis more than 100 mL within the last 30 days

• Change in chronic medication within the last 30 days

• History of elevated serum creatinine (> than or equal to 2 mg/dl) within 30 days or at screening

• History of lung and other solid organ transplantation

• Wait-listed for lung or other solid organ transplant

• Known intolerance to inhaled hypertonic saline