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Completed

NCT Number: NCT00180635

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital

London, SW3 6LY, United Kingdom

About this study

Nitric oxide (NO) is produced by resident and inflammatory cells in the respiratory tract by the enzyme NO synthase (NOS), which exists in three isoforms: neuronal NOS (nNOS), inducible NOS (iNOS), and endothelial NOS. NO production is increased in patients with COPD, and the production of NO under oxidative stress conditions generates reactive nitrogen species that may amplify the inflammatory response in COPD.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aminoguanidine

Drug

500mg

Other names: Nebulased Aminoguanidine

Placebos

Drug

2ml

Other names: Nebulase saline solution

Primary outcomes

  1. Bronchial exhale nitric oxide (JNO)

    Time frame: 24 hours

    Bronchial exhale nitric oxide (JNO) as assessed by Chemo luminescence

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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