Chronic Obstructive Pulmonary DiseaseNCT00180635
NO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD
A study testing Aminoguanidine in people with Chronic Obstructive Pulmonary Disease, run by Imperial College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Aminoguanidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2003to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, SW3 6LY
About this study
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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Aminoguanidine, Placebos
- Keywords
- COPD, Aminoguanidine, Nitric oxide
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminoguanidineDrug
Also called Nebulased Aminoguanidine
500mg
PlacebosDrug
Also called Nebulase saline solution
2ml
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers non smoker | Experimental | Control group Receives: Drug: Aminoguanidine; Drug: Placebos |
| Healthy volunteers smoker | Experimental | More than 10 pack-years Receives: Drug: Aminoguanidine; Drug: Placebos |
| Chronic Obstructive Pulmonary Disease COPD | Experimental | COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease guidelines Receives: Drug: Aminoguanidine; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchial exhale nitric oxide (JNO)
Bronchial exhale nitric oxide (JNO) as assessed by Chemo luminescence
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergei A Kharitonov, MD PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180635
- Sponsor's protocol ID
- 02-104-170903
- Status last verified
- Jul 2019
- First submitted
- 9 Sep 2005
- Last updated
- 10 Jul 2019
- Results posted
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00180635
- Acronym / sponsor ID
- 02-104-170903
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Aminoguanidine, Nitric oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Oct 2003 (actual)
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers non smoker | Experimental | Drug: Aminoguanidine, Drug: PlacebosControl group |
| Healthy volunteers smoker | Experimental | Drug: Aminoguanidine, Drug: PlacebosMore than 10 pack-years |
| Chronic Obstructive Pulmonary Disease COPD | Experimental | Drug: Aminoguanidine, Drug: PlacebosCOPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease guidelines |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
- Moderate COPD
- Able to comprehend and grant a written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AminoguanidineAlso: Nebulased Aminoguanidine500mg | Drug | Chronic Obstructive Pulmonary Disease COPD, Healthy volunteers non smoker, Healthy volunteers smoker |
| PlacebosAlso: Nebulase saline solution2ml | Drug | Chronic Obstructive Pulmonary Disease COPD, Healthy volunteers non smoker, Healthy volunteers smoker |
Primary outcome
Bronchial exhale nitric oxide (JNO)
Time frame: 24 hours
Bronchial exhale nitric oxide (JNO) as assessed by Chemo luminescence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Results publication: PubMed 18719059Brindicci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergei A Kharitonov, MD PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aminoguanidine in people with Chronic Obstructive Pulmonary Disease, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchial exhale nitric oxide (JNO) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00180635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.