Viewing Study NCT00159380



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Study NCT ID: NCT00159380
Status: COMPLETED
Last Update Posted: 2019-07-10
First Post: 2005-09-09

Brief Title: Nitric Oxide NO Donors and Inhibitors Study Study to Evaluate L-Arginine and Aminoguanidine in Asthmatic Subjects
Sponsor: Imperial College London
Organization: Imperial College London

Study Overview

Official Title: A Double Blind Crossover Placebo-controlled Study to Evaluate the Effect of L-arginine and Aminoguanidine on Bronchial Alveolar and Nasal NO and NO Metabolites
Status: COMPLETED
Status Verified Date: 2019-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The primary aim of this study is to investigate the effects of oral and inhaled administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled NO and NO metabolites in exhaled breath condensate saliva and nasal lavage fluid in normal and asthmatic subjects
Detailed Description: Nitric oxide NO is produced by a variety of cells within the respiratory tract particularly airway epithelial cells and its increased concentration in asthma is likely to derive from inducible NO synthase iNOS expressed in inflamed airways To evaluate whether an increased bronchial flux of NO ie airway wall NO flux Jno in picoliters per second produced in the large airways is due to an enzyme overexpression we administered a relatively selective iNOS inhibitor aminoguanidine by nebulization in a double-blind placebo-controlled manner in asthmatic and healthy subjects and also investigated whether the same concentration of inhibitor has any effect on NO produced in the peripheral lungs ie alveolar NO concentration Calv in parts per billion ppb or on the diffusing capacity of NO Dno in picoliters per second-1 per ppb-1 in the airways Aminoguanidine administration resulted in a significant reduction in Jno compared with administration of the saline solution control in eight healthy subjects and in eight patients with asthma but caused no significant changes in Calv or in Dno in either group

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None