NO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD - Full Text View

Sponsored by:	Imperial College London
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00180635

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, induced sputum, nasal lavage and mouth wash fluid in healthy non-smokers, current smokers and patients with COPD.

Condition	Intervention
Healthy Volunteers (Non-Smoker) Healthy Volunteers (Smoker) Chronic Obstructive Pulmonary Disease	Procedure: Inhalation of aminoguanidine and oral intake and inhalation of L-arginine Procedure: Exhaled Breath Condensate Procedure: Nasal Nitric Oxide Procedure: Nasal Lavage Procedure: Spirometry

MedlinePlus related topics: Antioxidants COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Nitric oxide Arginine Arginine hydrochloride Pimagedine

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 and Alveolar Nitric Oxide and Nitric Oxide Metabolites in Exhaled Air, Breath Condensate, Nasal Lavage, Mouth Wash Fluid, and Induced Sputum in 7 Healthy Non-Smokers, 10 Smokers and 12 COPD Patients

Further study details as provided by Imperial College London:

Primary Outcome Measures:

nitric oxide

Estimated Enrollment:	29
Study Start Date:	October 2003
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy non-smokers
Normal spirometry (FEV1 >90 % predicted; exhaled NO bigger than or equal to 10 ppb; flow 50 ml/s)
At risk (current smokers)
- Normal spirometry, with or without chronic symptoms (cough, sputum production)
- FEV1 reversibility of <15% after inhaled beta2-agonists*
Moderate COPD
- FEV1 greater than or equal to 30% and < 80%
- FEV1/FVC < 70% predicted
- FEV1 reversibility of <15% after inhaled beta2-agonists
- With or without chronic symptoms (cough, sputum production, dyspnea)
Able to comprehend and grant a written informed consent

Exclusion Criteria:

Concomitant use or pre-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: NCT00180635

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

Study ID Numbers:	02-104-170903
Study First Received:	September 9, 2005
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00180635
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Nitric Oxide
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Stress
Healthy
Pimagedine
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents

Protective Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009