The Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic Fibrosis

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this trial is to determine the safety and effect on pulmonary function of 14 days of inhaled L-arginine versus placebo administered over a period of 14 days in a cohort of CF patients.

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

Details

• Lead Sponsor: The Hospital for Sick Children

Criteria

Inclusion Criteria:

• Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride concentration > 60 mEq/L and/or two well characterized disease causing CFTR gene mutations

• 14 years of age and older at enrollment

• Clinically stable at enrollment

• Ability to comply with medication use, study visits and study procedures

• FEV1 % predicted > 40% < 80 % as calculated by reference equations

Exclusion Criteria:

• Respiratory culture positive for: B. cepacia complex within past year or at screening

• Use of systemic corticosteroids within 30 days of screening

• Use of intravenous antibiotics or oral quinolones within 14 days of screening

• History of biliary cirrhosis, portal hypertension, or splenomegaly

• Other major organ dysfunction

• History of lung transplantation or currently on lung transplant list

• Supplemental oxygen therapy

• Oxygen saturation < 95 % on room air

• Positive pregnancy test at screening

• Investigational drug use within 30 days of screening

• History of alcohol, illicit drug or medication abuse within 1 year of screening

• Acute respiratory symptoms

• Inability to take any form of bronchodilator

• Wheezing at the time of study