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CompletedNCT00180635Updated Jul 10, 2019

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

An interventional study of Aminoguanidine and Placebos in Chronic Obstructive Pulmonary Disease, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-10.

Sponsored by Imperial College London · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Oct 2003, registered Sep 2005).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • Aminoguanidine
  • Nitric oxide
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 30 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Healthy volunteers non smoker

    Control group

    Drug: Aminoguanidine · Drug: Placebos

  • Experimental
    Healthy volunteers smoker

    More than 10 pack-years

    Drug: Aminoguanidine · Drug: Placebos

  • Experimental
    Chronic Obstructive Pulmonary Disease COPD

    COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease guidelines

    Drug: Aminoguanidine · Drug: Placebos

Interventions

  • DrugAminoguanidine

    500mg

    Also known as: Nebulased Aminoguanidine

  • DrugPlacebos

    2ml

    Also known as: Nebulase saline solution

06

What researchers measure

Primary outcomes

  1. Bronchial exhale nitric oxide (JNO)

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

    Time frame: 24 hours

07

Study locations

1 site
  • Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
    London, SW3 6LY, United Kingdom
08

References and documents

Publications

  • Brindicci C, Ito K, Torre O, Barnes PJ, Kharitonov SA. Effects of aminoguanidine, an inhibitor of inducible nitric oxide synthase, on nitric oxide production and its metabolites in healthy control subjects, healthy smokers, and COPD patients. Chest. 2009 Feb;135(2):353-367. doi: 10.1378/chest.08-0964. Epub 2008 Aug 21. PubMed 18719059 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00180635
Lead sponsor
Imperial College London
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Oct 2003
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Jul 10, 2019

Study contacts

Sergei A Kharitonov, MD PhD
principal investigator · Imperial College London
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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