Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
The Hospital for Sick Children Irvin Foundation |
---|---|
Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00405665 |
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.
Condition | Intervention | Phase |
---|---|---|
Cystic Fibrosis |
Drug: L-arginine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study of the Short Term Safety and Efficacy of Inhaled L-Arginine in Patients With Cystic Fibrosis |
Estimated Enrollment: | 20 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: L-arginine
Group 1 will receive the active treatment followed by the inactive treatment. The active treatment phase will consist of L-arginine 250 mg/ml dispensed in 2.2 ml vials, from which the patient will take 2ml (500mg) and dilute with 3ml of sterile water to give 5ml of a 100mg/ml solution. Dosing in the inactive treatment phase will consist of a placebo of similar osmolarity and appearance will be formulated and dosed in a similar fashion. It will consist of 2.2ml vials of 1110mmol/L hypertonic saline. Again, the patient will take 2ml and dilute with 3ml of sterile water to give a 445mmol/L solution which has similar tonicity (10%) to the L-arginine. Both treatment phases will be administered by inhalation with a PARI eFLOW device.
|
2: Experimental |
Drug: L-arginine
Group 2 will receive the inactive treatment followed by the active treatment.
|
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 NO formation remain incompletely understood, there is evidence that low NO formation contributes to lung pathophysiology in CF. Constitutive endogenous formation of Nitric oxide (NO) in airways is thought to play a role in neurotransmission, smooth muscle relaxation and bronchodilation. Previous animal experiments have shown that the addition of L-arginine, the precursor of enzymatic NO formation, resulted in a significantly greater relaxation of tracheas. There is also evidence that a single dose of inhaled L-arginine improves pulmonary function in CF. In this study we will assess the effect of L-arginine inhalation on lung function, nitric oxide formation, airway inflammation and bacterial infection in CF patients.
Ages Eligible for Study: | 14 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shawn Kerrigan, Coordinator | 416-813-7654 ext 2016 | shawn.kerrigan@sickkids.ca |
Canada, Ontario | |
The Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada, M5G 1X8 | |
Contact: Felix Ratjen, MD 416 813 6167 felix.ratjen@sickkids.ca | |
Principal Investigator: Felix Ratjen, MD | |
Sub-Investigator: Hartmut Grasemann, MD | |
St. Michael's Hospital | Recruiting |
Toronto, Ontario, Canada, M5B 1W8 | |
Contact: Elizabeth Tullis, MD 416-864-5406 tullise@smh.toronto.on.ca | |
Principal Investigator: Elizabeth Tullis, MD |
Principal Investigator: | Felix Ratjen, MD | The Hospital for Sick Children, Toronto Canada |
Responsible Party: | The Hospital for Sick Children ( Felix Ratjen/Principal Investigator ) |
Study ID Numbers: | 1000009282 |
Study First Received: | November 28, 2006 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00405665 |
Health Authority: | Canada: Health Canada |
Cystic Fibrosis L-Arginine Pediatrics pulmonary function |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis |
Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
Pathologic Processes |