Nitric Oxide (NO) Donors and Inhibitors Study: Study to Evaluate L-Arginine and Aminoguanidine in Asthmatic Subjects

This study has been completed.

First Received: September 9, 2005 Last Updated: April 4, 2008 History of Changes

Sponsored by:	Imperial College London
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00159380

Purpose

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.

Condition	Intervention
Asthma	Procedure: Inhalation of aminoguanidine and oral intake and inhalation of L-arginine Procedure: Exhaled Breath Condensate Procedure: Nasal Lavage Procedure: Saliva Procedure: Spirometry

MedlinePlus related topics: Asthma

Drug Information available for: Arginine Pimagedine Arginine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Crossover Assignment
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 in Exhaled Air, Breath Condensate, Saliva, Nasal Lavage Fluid and Induced Sputum in 10 Normal and 15 Asthmatic Subjects

Further study details as provided by Imperial College London:

Primary Outcome Measures:

Exhaled nitric oxide, exhaled breath condensate, nasal lavage, saliva, spirometry

Estimated Enrollment:	25
Study Start Date:	September 2003
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy non-smokers (n=10):

Nonatopic subjects (exhaled NO greater than or equal to 10 ppb; flow 50 ml/s)
Normal spirometry
Able to comprehend and grant a written informed consent

Asthmatic subjects (n=15):

Forced expiratory volume in one second (FEV1) of no less than 70% of predicted (exhaled NO greater than or equal to 15 ppb; flow 50 ml/s)
Clinically stable (steroid-naïve or taking no > 600 mcg/day of inhaled steroids)
Able to comprehend and grant a written informed consent

Exclusion Criteria:

Currently smoking
Any lung disease other than asthma which may interfere with the study
Treatment within the last 4 weeks with oral steroids
Respiratory infection within 4 weeks prior to entry into the trial
Females who are pregnant or lactating
History of current or past drug or alcohol abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159380

Locations

United Kingdom
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, United Kingdom, SW3 6LY

Sponsors and Collaborators

Imperial College London

Investigators

Principal Investigator:

Sergei A Kharitonov, MD, PhD

Imperial College London

More Information

No publications provided

Study ID Numbers:	2002AT033B
Study First Received:	September 9, 2005
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00159380 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

Healthy Volunteers

Study placed in the following topic categories:

Nitric Oxide
Asthma
Healthy
Pimagedine

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Pimagedine

ClinicalTrials.gov processed this record on May 06, 2009