Status:
COMPLETED
The Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic Fibrosis
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
14+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Despite the inflammatory nature of lung disease in CF, nitric oxide (NO) formation as well as the expression of NOS2 has been found to be decreased in CF airways. While the reasons for impaired airway...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00405665
Start Date
November 1 2006
End Date
June 1 2009
Last Update
September 2 2013
Active Locations (2)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
2
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8