Nitric Oxide (NO) Donors and Inhibitors Study: Study to Evaluate L-Arginine and Aminoguanidine in Asthmatic Subjects
A Double Blind, Crossover Placebo-controlled Study to Evaluate the Effect of L-arginine and Aminoguanidine on Bronchial, Alveolar and Nasal NO and NO Metabolites
1 other identifier
interventional
16
1 country
1
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, saliva and nasal lavage fluid in normal and asthmatic subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started Sep 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedJuly 10, 2019
July 1, 2019
1.5 years
September 9, 2005
July 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Bronchial exhale nitric oxide
Bronchial exhale nitric oxide (JNo) assessed by chemo luminescence
6 hours
Peripheral exhaled nitric oxide
Peripheral exhaled nitric oxide(CALV) assessed by chemo luminescence
6 hours
Study Arms (2)
Healthy volunteers
EXPERIMENTAL8 non smokers non asthmatic
Asthma volunteers
EXPERIMENTAL8 asthmatic mild
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, SW3 6LY, United Kingdom
Related Publications (1)
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.
PMID: 17550932RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sergei A Kharitonov, MD, PhD
Imperial College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 12, 2005
Study Start
September 1, 2003
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
July 10, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share