Back to resultsNO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Aminoguanidine
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Aminoguanidine, Nitric oxide
Eligibility Criteria
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
Sites / Locations
- Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Healthy volunteers non smoker
Healthy volunteers smoker
Chronic Obstructive Pulmonary Disease COPD
Arm Description
Control group
More than 10 pack-years
COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease guidelines
Outcomes
Primary Outcome Measures
Bronchial exhale nitric oxide (JNO)
Bronchial exhale nitric oxide (JNO) as assessed by Chemo luminescence
Secondary Outcome Measures
Full Information
NCT ID
NCT00180635
First Posted
September 9, 2005
Last Updated
July 9, 2019
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT00180635
Brief Title
NO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2003 (Actual)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Aminoguanidine, Nitric oxide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers non smoker
Arm Type
Experimental
Arm Description
Control group
Arm Title
Healthy volunteers smoker
Arm Type
Experimental
Arm Description
More than 10 pack-years
Arm Title
Chronic Obstructive Pulmonary Disease COPD
Arm Type
Experimental
Arm Description
COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease guidelines
Intervention Type
Drug
Intervention Name(s)
Aminoguanidine
Other Intervention Name(s)
Nebulased Aminoguanidine
Intervention Description
500mg
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Nebulase saline solution
Intervention Description
2ml
Primary Outcome Measure Information:
Title
Bronchial exhale nitric oxide (JNO)
Description
Bronchial exhale nitric oxide (JNO) as assessed by Chemo luminescence
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergei A Kharitonov, MD PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6LY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18719059
Citation
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.
Results Reference
result
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NO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD
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