Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-02 @ 4:45 AM
Study NCT ID:
NCT00180635
Status:
COMPLETED
Last Update Posted:
2019-07-10
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004479', 'term': 'pimagedine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bronchial exhale nitric oxide (JNO)', 'timeFrame': '24 hours', 'description': 'Bronchial exhale nitric oxide (JNO) as assessed by Chemo luminescence'}]}, 'conditionsModule': {'keywords': ['COPD', 'Aminoguanidine', 'Nitric oxide'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '18719059', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy non-smokers\n* Normal spirometry (FEV1 \\>90 % predicted; exhaled NO bigger than or equal to 10 ppb; flow 50 ml/s)\n* At risk (current smokers)\n\n * Normal spirometry, with or without chronic symptoms (cough, sputum production)\n * FEV1 reversibility of \\<15% after inhaled beta2-agonists\\*\n* Moderate COPD\n\n * FEV1 greater than or equal to 30% and \\< 80%\n * FEV1/FVC \\< 70% predicted\n * FEV1 reversibility of \\<15% after inhaled beta2-agonists\n * With or without chronic symptoms (cough, sputum production, dyspnea)\n* Able to comprehend and grant a written informed consent\n\nExclusion Criteria:\n\n* Concomitant use or pre-treatment within the last 4 weeks with oral steroids\n* Respiratory infection within 4 weeks prior to entry into the trial\n* Females who are pregnant or lactating\n* History of current or past drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT00180635', 'briefTitle': 'NO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '02-104-170903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers non smoker', 'description': 'Control group', 'interventionNames': ['Drug: Aminoguanidine', 'Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers smoker', 'description': 'More than 10 pack-years', 'interventionNames': ['Drug: Aminoguanidine', 'Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'Chronic Obstructive Pulmonary Disease COPD', 'description': 'COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease guidelines', 'interventionNames': ['Drug: Aminoguanidine', 'Drug: Placebos']}], 'interventions': [{'name': 'Aminoguanidine', 'type': 'DRUG', 'otherNames': ['Nebulased Aminoguanidine'], 'description': '500mg', 'armGroupLabels': ['Chronic Obstructive Pulmonary Disease COPD', 'Healthy volunteers non smoker', 'Healthy volunteers smoker']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['Nebulase saline solution'], 'description': '2ml', 'armGroupLabels': ['Chronic Obstructive Pulmonary Disease COPD', 'Healthy volunteers non smoker', 'Healthy volunteers smoker']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6LY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Sergei A Kharitonov, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}