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

This study has been completed.
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00180635
First received: September 9, 2005
Last updated: April 4, 2008
Last verified: April 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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

No publications provided by Imperial College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00180635     History of Changes
Other Study ID Numbers: 02-104-170903
Study First Received: September 9, 2005
Last Updated: April 4, 2008
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on April 14, 2014