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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00180635

Enrollment

Registered

2005-09-16

Start date

2003-10-31

Completion date

2006-07-31

Last updated

2019-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Aminoguanidine, Nitric oxide

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.

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.

Interventions

DRUGAminoguanidine

500mg

DRUGPlacebos

2ml

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Bronchial exhale nitric oxide (JNO)	24 hours	Bronchial exhale nitric oxide (JNO) as assessed by Chemo luminescence

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026