Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-07 @ 8:17 PM
Study NCT ID:
NCT00331292
Status:
TERMINATED
Last Update Posted:
2008-10-16
First Post:
2006-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Methodology Study To Look At Genes In Lung Cells And Tissue From Asthmatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'lastUpdateSubmitDate': '2008-10-15', 'studyFirstSubmitDate': '2006-05-26', 'studyFirstSubmitQcDate': '2006-05-26', 'lastUpdatePostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-29', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Asthma bronchoscopy'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to identify a gene or panel of genes which are differentially expressed in lung cells and tissue from asthmatic patients following administration of Ipratropium bromide and eiTher nebulised Albuterol or saline. Each subject in this study will undergo two bronchoscopies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Have a history of intermittant asthma.\n* Have asthma symptoms less than once per week.\n* Have no other significant disease.\n* Do not take regular oral or inhaled steroids.\n* Are a non-smoker for the past 12 months with a pack history of less than 5 years.\n\nExclusion criteria:\n\n* Have a history of drug or alcohol abuse.\n* Have poorly controlled asthma or a history of life-threatening asthma.\n* Have a history of hypersensitivity to bronchodilators.\n* Are unable to abstain from inhaled steroids from 14 days prior to the first study visit until completion of the study.\n* Have received oral steroids within 3 months of study entry.\n* Have been hospitalized for your asthma within 3 months of study entry.\n* Have had treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.'}, 'identificationModule': {'nctId': 'NCT00331292', 'briefTitle': 'A Methodology Study To Look At Genes In Lung Cells And Tissue From Asthmatic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Identify a Transcriptomic Profile Indicative of Cycle AMP Pathway Activation in the Lung', 'orgStudyIdInfo': {'id': 'CRB100706'}}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'GSK Clinical Trials, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'GSK'}}}}