NO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00180635
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 4, 2015
Information provided by:
Imperial College London

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

Condition or disease Intervention/treatment Phase
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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : October 2003
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Primary Outcome Measures :
  1. nitric oxide

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00180635

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
Principal Investigator: Sergei A Kharitonov, MD PhD Imperial College London

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00180635     History of Changes
Other Study ID Numbers: 02-104-170903
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: April 2008

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents
Enzyme Inhibitors