{ "FullStudy":{ "Rank":217773, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517022", "OrgStudyIdInfo":{ "OrgStudyId":"SKS/Med/NI1161" }, "Organization":{ "OrgFullName":"All India Institute of Medical Sciences, New Delhi", "OrgClass":"OTHER" }, "BriefTitle":"Intensive Smoking-cessation Intervention Versus Smoking-cessation Advice in Smear-positive Patients With Pulmonary Tuberculosis", "OfficialTitle":"Impact of a Package of Intensive Smoking-cessation Interventions Versus Smoking-cessation Advice on Outcomes in Smear-positive Patients With Pulmonary Tuberculosis; a Randomised Controlled Trial (STB_RCT)." }, "StatusModule":{ "StatusVerifiedDate":"October 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2016", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"June 23, 2011", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"October 12, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 13, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"S.K.SHARMA", "ResponsiblePartyInvestigatorTitle":"Professor and Head", "ResponsiblePartyInvestigatorAffiliation":"All India Institute of Medical Sciences, New Delhi" }, "LeadSponsor":{ "LeadSponsorName":"All India Institute of Medical Sciences, New Delhi", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"University of Cape Town", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Sri Venkateswara Institute of Medical Sciences University", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The aim of the study is to determine the impact of a package of smoking-cessation interventions on a composite measure of Tuberculosis (TB) treatment-related outcomes.\n\nGiven the lack of objective clinical data/evidence about the impact of smoking-cessation on TB-related outcomes, yet subjective expert opinion that smoking cessation is highly likely to be beneficial particularly in patients with TB, this study proposes to determine the impact of an intensive package of smoking-cessation interventions aimed to promote smoking-cessation (counseling plus nicotine replacement therapy, NRT), on patient response to anti-tuberculosis therapy. This is to be compared with the structured counselling for smoking-cessation that is recommended to be routinely provided by health care workers to all patients who are smokers. If the results prove that such a smoking-cessation PI indeed improves outcomes in TB patients, such information would strongly motivate for the institution of more intensive smoking-cessation interventions in TB clinics than is currently being employed for TB patients", "DetailedDescription":"No clinical trials have been done to determine if the cessation of smoking has any influence on outcome in tuberculosis patients. In particular, if smoking cessation leads to a higher rate of sputum culture-conversion at 2 months, TB transmission rates should be reduced. Such targeted smoking-cessation intervention may be more successful than general public education strategies in reducing the spread of TB in high-incidence countries Tuberculosis (TB) . The WHO has estimated that approximately a third of the world's population is infected with Mycobacterium tuberculosis, and approximately 2 million die from TB every year. Tobacco smoking, which is the single most preventable cause of death in the world today, appears to be an important risk factor for TB disease and mortality, especially in countries such as India. The smoking-TB association has major public health implications because in many of the developing countries where there is a high prevalence of TB, smoking is also a common practice. Smoking is widespread, with approximately a third of the global population aged 15 years or above being smokers, but has reached epidemic proportions in countries such as India, China and Russia. For example, in India more than half of the rural male population is estimated to smoke and India accounts for 1.85 million TB cases each year. Therefore in India, as for other developing countries, the co-existence of a high TB and smoking burden is a major health concern, and further underscores the importance of promoting smoking cessation to the general public. In India, studies have shown a strong association between tobacco and TB mortality. An estimated third of male TB deaths in India may be due to smoking. However, there is concern that many of the published studies did not adequately control for bias and confounding (that may have caused spurious associations)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Tuberculosis" ] }, "KeywordList":{ "Keyword":[ "smoking cessation", "early sputum smear conversion" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"800", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Control arm", "ArmGroupType":"No Intervention", "ArmGroupDescription":"Control arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along with routine DOTS treatment" },{ "ArmGroupLabel":"Intervention arm", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Cessation arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along and nicotine replacement therapy(NRT) and routine DOTS treatment", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: nicotine replacement therapy" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"nicotine replacement therapy", "InterventionDescription":"nicotine replacement therapy 2mg for patients cessation arm for period of 6 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Intervention arm" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Nicogum 2mg Cipla pharmaceuticals" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"1. Change in TB Score at second month and sixth month", "PrimaryOutcomeDescription":"Composite score for objective and subjective improvement measured at baseline, second month and sixth month", "PrimaryOutcomeTimeFrame":"Measured at baseline, second month and sixth month." },{ "PrimaryOutcomeMeasure":"Sputum culture conversion", "PrimaryOutcomeDescription":"Sputum culture conversion at second month using solid/liquid culture technique", "PrimaryOutcomeTimeFrame":"Measured at baseline and second month" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Sputum smear conversion", "SecondaryOutcomeDescription":"Protocol was amended to access sputum conversion weekly up to second month", "SecondaryOutcomeTimeFrame":"Measured at baseline, second week, fourth week, second month and sixth months" },{ "SecondaryOutcomeMeasure":"Mortality at sixth month", "SecondaryOutcomeDescription":"To determine number of mortality at the end of follow-up", "SecondaryOutcomeTimeFrame":"Sixth month" },{ "SecondaryOutcomeMeasure":"More than 10% weight gain at six months", "SecondaryOutcomeDescription":"To determine rate of weight gain after completion of treatment", "SecondaryOutcomeTimeFrame":"Sixth month" },{ "SecondaryOutcomeMeasure":"Proportion of subjects in each group that have quit smoking at second month", "SecondaryOutcomeDescription":"To determine the rate of smoking cessation in the cohort", "SecondaryOutcomeTimeFrame":"Sixth month" },{ "SecondaryOutcomeMeasure":"Treatment completion", "SecondaryOutcomeTimeFrame":"Six months for new cases and eight months for re-treatment cases following regimen 2" },{ "SecondaryOutcomeMeasure":"Cure, failure and default rate", "SecondaryOutcomeDescription":"To determine cure, failure and default rate in the cohort", "SecondaryOutcomeTimeFrame":"At sixth month" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nany adult (> 18 years)\nRecently diagnosed (primary TB/Relapse TB) smear-positive TB patient who self-reports to smoke at least 10 whole cigarettes or bidis (rolled tobacco leaf) per day, every day\n\nExclusion Criteria:\n\npatients will be excluded from recruitment to the study if they fall into any one or more of these exclusion categories:\n\nInability to give consent or < 18 years\nPatients who self-report to smoke less than 10 whole cigarettes/bidis per day\nTB patients who have already started anti-tuberculosis therapy for more than 1 week.\nPatients with known multidrug-resistant TB (or XDR) (information provided by patient or the information is available in the clinic folder).\nKnown HIV-positive patients\nContra-indications to NRT (patients with a history of severe cardiovascular disease including arrhythmias, recent myocardial infarction (within the last 6 months), recent cerebrovascular incident (6 months), and/ or history of peripheral vascular disease, phaeochromocytoma, poorly controlled diabetes mellitus, hyperthyroidism, renal/hepatic impairment or gastritis/peptic ulcers). Patients with asthma or depression will also be excluded, as quitting may have an effect on medications used for these conditions. Patients with severe skin disorders (such as psoriasis or eczema) will also be excluded.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Surendra K Sharma, MD, Ph.D.", "OverallOfficialAffiliation":"AIIMS, New Delhi", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"All India Institute of Medical Sciences, Ansari Nagar", "LocationCity":"New Delhi", "LocationZip":"110029", "LocationCountry":"India" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000009538", "InterventionMeshTerm":"Nicotine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000005731", "InterventionAncestorTerm":"Ganglionic Stimulants" },{ "InterventionAncestorId":"D000001337", "InterventionAncestorTerm":"Autonomic Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000018722", "InterventionAncestorTerm":"Nicotinic Agonists" },{ "InterventionAncestorId":"D000018679", "InterventionAncestorTerm":"Cholinergic Agonists" },{ "InterventionAncestorId":"D000018678", "InterventionAncestorTerm":"Cholinergic Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M11061", "InterventionBrowseLeafName":"Nicotine", "InterventionBrowseLeafAsFound":"Nicotine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2610", "InterventionBrowseLeafName":"Central Nervous System Stimulants", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19380", "InterventionBrowseLeafName":"Nicotinic Agonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19342", "InterventionBrowseLeafName":"Cholinergic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000014376", "ConditionMeshTerm":"Tuberculosis" },{ "ConditionMeshId":"D000014397", "ConditionMeshTerm":"Tuberculosis, Pulmonary" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009164", "ConditionAncestorTerm":"Mycobacterium Infections" },{ "ConditionAncestorId":"D000000193", "ConditionAncestorTerm":"Actinomycetales Infections" },{ "ConditionAncestorId":"D000016908", "ConditionAncestorTerm":"Gram-Positive Bacterial Infections" },{ "ConditionAncestorId":"D000001424", "ConditionAncestorTerm":"Bacterial Infections" },{ "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" },{ "ConditionAncestorId":"D000012141", "ConditionAncestorTerm":"Respiratory Tract Infections" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M15710", "ConditionBrowseLeafName":"Tuberculosis", "ConditionBrowseLeafAsFound":"Tuberculosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15730", "ConditionBrowseLeafName":"Tuberculosis, Pulmonary", "ConditionBrowseLeafAsFound":"Pulmonary Tuberculosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10702", "ConditionBrowseLeafName":"Mycobacterium Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3303", "ConditionBrowseLeafName":"Bacterial Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M17835", "ConditionBrowseLeafName":"Gram-Positive Bacterial Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13561", "ConditionBrowseLeafName":"Respiratory Tract Infections", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" } ] } } } } } }