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CompletedNCT00159380Updated Jul 10, 2019

Nitric Oxide (NO) Donors and Inhibitors Study: Study to Evaluate L-Arginine and Aminoguanidine in Asthmatic Subjects

An interventional study of Aminoguanidine and Placebos in Asthma, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 21 Years to 60 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 2 years after the study started (first participant enrolled Sep 2003, registered Sep 2005).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
21 Years to 60 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, saliva and nasal lavage fluid in normal and asthmatic subjects.

Read the detailed description

Nitric oxide (NO) is produced by a variety of cells within the respiratory tract, particularly airway epithelial cells, and its increased concentration in asthma is likely to derive from inducible NO synthase (iNOS) expressed in inflamed airways. To evaluate whether an increased bronchial flux of NO (ie, airway wall NO flux [Jno] in picoliters per second) produced in the large airways is due to an enzyme overexpression, we administered a relatively selective iNOS inhibitor, aminoguanidine, by nebulization in a double-blind, placebo-controlled manner in asthmatic and healthy subjects and also investigated whether the same concentration of inhibitor has any effect on NO produced in the peripheral lungs (ie, alveolar NO concentration [Calv] in parts per billion [ppb]) or on the diffusing capacity of NO (Dno) [in picoliters per second-1 per ppb-1) in the airways. Aminoguanidine administration resulted in a significant reduction in Jno compared with administration of the saline solution control in eight healthy subjects and in eight patients with asthma but caused no significant changes in Calv or in Dno in either group.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 16 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma 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 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Healthy non-smokers (n=10):

  • Nonatopic subjects (exhaled NO greater than or equal to 10 ppb; flow 50 ml/s)
  • Normal spirometry
  • Able to comprehend and grant a written informed consent

Asthmatic subjects (n=15):

  • Forced expiratory volume in one second (FEV1) of no less than 70% of predicted (exhaled NO greater than or equal to 15 ppb; flow 50 ml/s)
  • Clinically stable (steroid-naïve or taking no > 600 mcg/day of inhaled steroids)
  • Able to comprehend and grant a written informed consent

Exclusion criteria

Exclusion Criteria:

  • Currently smoking
  • Any lung disease other than asthma which may interfere with the study
  • 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
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Study design

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

Study arms

  • Experimental
    Healthy volunteers

    8 non smokers non asthmatic

    Drug: Placebos

  • Experimental
    Asthma volunteers

    8 asthmatic mild

    Drug: Aminoguanidine

Interventions

  • DrugAminoguanidine

    500mg

    Also known as: Inhalation of aminoguanidine

  • DrugPlacebos

    2ml

    Also known as: Nebulase saline solution

06

What researchers measure

Primary outcomes

  1. Bronchial exhale nitric oxide

    Bronchial exhale nitric oxide (JNo) assessed by chemo luminescence

    Time frame: 6 hours

  2. Peripheral exhaled nitric oxide

    Peripheral exhaled nitric oxide(CALV) assessed by chemo luminescence

    Time frame: 6 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, Barnes PJ, Kharitonov SA. Effect of an inducible nitric oxide synthase inhibitor on differential flow-exhaled nitric oxide in asthmatic patients and healthy volunteers. Chest. 2007 Aug;132(2):581-8. doi: 10.1378/chest.06-3046. Epub 2007 Jun 5. PubMed 17550932 ↗

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
NCT00159380
Lead sponsor
Imperial College London
Responsible party
Sponsor
First posted
Sep 12, 2005
Start date
Sep 2003
Primary completion
Mar 2005
Completion
Mar 2005
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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