Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01676467
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2012-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sample Collection in Smoking Asthma
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum sputum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-07', 'studyFirstSubmitDate': '2012-08-21', 'studyFirstSubmitQcDate': '2012-08-28', 'lastUpdatePostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sputum and serum biomarkers', 'timeFrame': 'Day 10', 'description': 'Measurement of biomarkers of inflammation, including but not limited to: TNFα, IL-8, IFNγ, IP10 and eotaxin in sputum supernatant and serum will be collected and measured only once, at Visit 2 (Day 10).'}, {'measure': 'Sputum cell count', 'timeFrame': 'Day 10', 'description': 'Sputum cell count (total cells, differentials and absolute number) at Visit 2 (Day 10).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study will collect blood and sputum (phlegm) samples from subjects with asthma, smokers and normal healthy subjects, to compare the biological markers of disease and inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be selected by advertisements from the general population and primary care.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (healthy subjects):\n\n* Male or female, between 18 and 55 years of age, inclusive.\n* no clinically significant abnormalities.\n* able to produce an adequate induced sputum sample.\n* no history of chronic respiratory disease including asthma.\n* no history of allergic symptoms e.g., allergic rhinitis, eczema.\n* No other acute illness in the 6 weeks prior to Visit 1.\n\nAdditional Inclusion Criterion for Healthy Smoking Subjects\n\n* Be a smoker for \\>/= 1 year.\n\nAdditional Inclusion Criteria (Persistent Asthmatic Subjects):\n\n* No contraindications to the procedures in this study.\n* Symptoms compatible with asthma for at least 6 months prior to screening\n* Pre-bronchodilator FEV1 \\>/=50% predicted at Visit 1.\n* clinically stable asthma for at least 6 weeks prior to Visit 1.\n* No acute illness including asthma exacerbation requiring augmentation of therapy in the 6 weeks prior to Visit 1.\n* on current asthma controller therapy for \\>/= 6 weeks prior to Visit 1.\n\nAdditional Inclusion for Steroid Naïve Asthmatics (smoking or non-smoking)\n\n* Must not have received a regular course of inhaled or oral corticosteroids for at least 3 months prior to Visit 1.\n\nAdditional Inclusion for Smoking Asthmatics\n\n* Be a smoker for \\>/= 1 year prior to Visit 1.\n\nExclusion Criteria (healthy):\n\n* History of any clinically significant medical illness or medical disorders.\n* Diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or other significant respiratory disorder including significant occupational or environmental exposures with ongoing respiratory symptoms.\n* bronchodilator response of \\>/=12% and at least 200 mL from baseline or an FEV1 value \\<85% of predicted value at Visit 1.\n* positive urine pregnancy screening result.\n* recent history (within previous 6 months) of alcohol or drug abuse.\n* Positive urine toxicology screen for substances of abuse\n* positive serology test for HIV antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) at Visit 1.\n* Received an experimental antibody or biologic therapy within the 6 months prior to Visit 1, or received any other experimental therapy or new investigational agent within 60 days of Visit 1.\n* Is an employee or family member of the investigator, study centre or Sponsor.\n* Any condition that, in the opinion of the investigator, would complicate or compromise the study, or the well-being of the subject.\n* Use of any antioxidants within 1 week of Visit 1 and throughout the study period.\n* known allergies, hypersensitivity, or intolerance to short acting β-agonists (SABA).\n\nAdditional Exclusion Criterion for Healthy Non-smoking Subjects\n\n* subject is a smoker (regular or irregular), or has smoked or used nicotine-containing products within the 6 months prior to Visit 1.\n\nAdditional Exclusion Criteria (Persistent Asthma Subjects):\n\n* Diagnosis of allergic bronchopulmonary aspergillosis (ABPA), allergic bronchopulmonary mycosis (ABPM), or occupational asthma.\n* Diagnosis of COPD, cystic fibrosis, or other significant respiratory disorder including significant occupational or environmental exposures with ongoing respiratory symptoms.\n* Use of theophylline, N-acetyl cysteine, or any other anti-oxidants within 1 week of Visit 1 and throughout the study period.\n* positive test for tuberculosis at Visit 1.\n\nAdditional Exclusion Criterion for Non-smoking Asthmatic Subjects\n\n* subject is a smoker (regular or irregular), or has smoked or used nicotine-containing products within the 6 months prior to Visit 1.'}, 'identificationModule': {'nctId': 'NCT01676467', 'briefTitle': 'Sample Collection in Smoking Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Respivert Ltd'}, 'officialTitle': 'A Sample Collection Protocol for Disease Profiling of Smoking Asthma.', 'orgStudyIdInfo': {'id': 'ENA002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smoking asthma on steroids', 'description': 'Smokers with persistent asthma on background steroid therapy'}, {'label': 'Smoking asthma steroid naïve', 'description': 'Smokers with persistent asthma, steroid naive'}, {'label': 'asthma on steroids', 'description': 'Non-Smokers with persistent asthma on background steroid therapy'}, {'label': 'asthma, steroid naïve', 'description': 'Non-smokers with persistent asthma, steroid naive'}, {'label': 'Healthy smoking', 'description': 'Healthy smoking control subjects'}, {'label': 'Healthy non-smoking', 'description': 'Healthy non-smoking control subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA1 3UJ', 'city': 'Harrow', 'state': 'Middlesex', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], 'overallOfficials': [{'name': 'Dr Garth Rapeport', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Respivert Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Respivert Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}