{ "FullStudy":{ "Rank":217845, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516086", "OrgStudyIdInfo":{ "OrgStudyId":"191-092" }, "Organization":{ "OrgFullName":"Dey", "OrgClass":"INDUSTRY" }, "BriefTitle":"A 12-Week Study in Adult Subjects With Asthma", "OfficialTitle":"A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Study to Replicate Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects With Partly Controlled and Uncontrolled Asthma" }, "StatusModule":{ "StatusVerifiedDate":"November 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"November 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"November 24, 2014", "DispFirstSubmitQCDate":"November 24, 2014", "DispFirstPostDateStruct":{ "DispFirstPostDate":"December 11, 2014", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 24, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 11, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Dey", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This will be a multi-center, randomized, placebo controlled parallel-group study to Replicate Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects with Partly Controlled and Uncontrolled Asthma. Individual participation will be approximately 16 weeks, including 12 weeks of double-blind treatment.", "DetailedDescription":"The primary outcome measure is FEV1 (Forced Expiry Volume in 1 second) and the secondary outcome measure is Peak Expiratory Flow Rate (PEFR), Asthma Control Questionnaire (ACQ), Nighttime awakenings and rescue medication usage." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Asthma" ] }, "KeywordList":{ "Keyword":[ "Controlled", "uncontrolled" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"498", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Fluticasone Propionate (FP) - arm 1", "ArmGroupType":"Experimental", "ArmGroupDescription":"FP BID (twice daily)", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fluticasone Propionate (FP)" ] } },{ "ArmGroupLabel":"Fluticasone propionate (FP) - arm 2", "ArmGroupType":"Experimental", "ArmGroupDescription":"FP BID", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fluticasone Propionate (FP)" ] } },{ "ArmGroupLabel":"Fluticasone Propionate (FP) - arm 3", "ArmGroupType":"Experimental", "ArmGroupDescription":"FP BID", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fluticasone Propionate (FP)" ] } },{ "ArmGroupLabel":"FLuticasone Propionate (FP) - Arm 4", "ArmGroupType":"Experimental", "ArmGroupDescription":"FP BID", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fluticasone Propionate (FP)" ] } },{ "ArmGroupLabel":"Fluticasone Propionate (FP) - Arm 5", "ArmGroupType":"Experimental", "ArmGroupDescription":"FP BID", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fluticasone Propionate (FP)" ] } },{ "ArmGroupLabel":"Placebo - Arm 6", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo inhalation solution", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fluticasone Propionate (FP)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Fluticasone Propionate (FP)", "InterventionDescription":"FP Inhalation BID", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "FLuticasone Propionate (FP) - Arm 4", "Fluticasone Propionate (FP) - Arm 5", "Fluticasone Propionate (FP) - arm 1", "Fluticasone Propionate (FP) - arm 3", "Fluticasone propionate (FP) - arm 2", "Placebo - Arm 6" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "No other names applicable" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"FEV1 (Forced Expiry Volume in 1 second)", "PrimaryOutcomeTimeFrame":"FEV1 at Week 12" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Peak Expiratory Flow Rate (PEFR)", "SecondaryOutcomeTimeFrame":"PEFR at Week 12" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nA signed and dated written informed consent form prior to the conduct of any study procedures\nMales and females between ≥ 18 and ≤ 60 years old.\nNon-smoker for at least 1 year prior to Visit 1, with a smoking history of no more than 10 pack-years (e.g., 1 pack [20 cigarettes] per day for 10 years).\n\n6.Ability to understand and comply with the protocol requirements (including completion of daily PEFR, PFT and ACQ), instructions and protocol-stated restrictions.\n\n7.Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit. WOCBP include: any female who has experienced menarche and is not post-menopausal (defined as amenorrhea for at least 12 consecutive months), or has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). Women who are using acceptable contraceptive medications or devices to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) will be considered WOCBP.\n\nWOCBP must agree to avoid becoming pregnant for the duration of the study by using adequate contraception at study entry and throughout the trial. Examples of adequate contraception include the following:\n\nNorplant\nMedroxyprogesterone acetate injection\nOral contraception\nDouble-barrier method (e.g., condom and spermicide)\n\nAbstinence, with one of the above WOCBP will be advised to notify the Investigator of any changes in their pregnancy status or any change in contraceptive use.\n\n8.Agreement by subject to abide by the study protocol and its restrictions.\n\nExclusion Criteria:\n\nPast or present disease, excluding asthma, which as judged by the investigator, may place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives These diseases include, but are not limited to cardiovascular disease, malignancy, gastrointestinal disease, hepatic disease, diabetes type I or uncontrolled diabetes, type II, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis, COPD, eosinophilic bronchitis or pulmonary fibrosis).\nAn upper or lower respiratory tract infection within 4 weeks of Visit 1 and prior to Visit 2\nA history of hypersensitivity to the study drug or its components, including albuterol as rescue medication.\nHistory of illegal drug or alcohol abuse within the past 5 years.\nPregnant or lactating women.\nUse of > 8 inhalations per day of SABA on any two consecutive days from screening to randomization (Visits 1 and 2).\nUse of an investigational drug or device within 30 days prior to screening", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"60 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Imtiaz Chaudry", "OverallOfficialAffiliation":"Dey", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"CU Pharmaceutical Research", "LocationCity":"Rock Hill", "LocationState":"South Carolina", "LocationZip":"29732", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "MoreInfoModule":{} }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000068298", "InterventionMeshTerm":"Fluticasone" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000893", "InterventionAncestorTerm":"Anti-Inflammatory Agents" },{ "InterventionAncestorId":"D000001993", "InterventionAncestorTerm":"Bronchodilator Agents" },{ "InterventionAncestorId":"D000001337", "InterventionAncestorTerm":"Autonomic Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000018927", "InterventionAncestorTerm":"Anti-Asthmatic Agents" },{ "InterventionAncestorId":"D000019141", "InterventionAncestorTerm":"Respiratory System Agents" },{ "InterventionAncestorId":"D000003879", "InterventionAncestorTerm":"Dermatologic Agents" },{ "InterventionAncestorId":"D000018926", "InterventionAncestorTerm":"Anti-Allergic Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M250", "InterventionBrowseLeafName":"Fluticasone", "InterventionBrowseLeafAsFound":"Fluticasone propionate", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2798", "InterventionBrowseLeafName":"Anti-Inflammatory Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3851", "InterventionBrowseLeafName":"Bronchodilator Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19547", "InterventionBrowseLeafName":"Anti-Asthmatic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19721", "InterventionBrowseLeafName":"Respiratory System Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M5657", "InterventionBrowseLeafName":"Dermatologic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19546", "InterventionBrowseLeafName":"Anti-Allergic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"AAll", "InterventionBrowseBranchName":"Anti-Allergic Agents" },{ "InterventionBrowseBranchAbbrev":"Infl", "InterventionBrowseBranchName":"Anti-Inflammatory Agents" },{ "InterventionBrowseBranchAbbrev":"Derm", "InterventionBrowseBranchName":"Dermatologic Agents" },{ "InterventionBrowseBranchAbbrev":"Resp", "InterventionBrowseBranchName":"Respiratory System Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001249", "ConditionMeshTerm":"Asthma" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001982", "ConditionAncestorTerm":"Bronchial Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" },{ "ConditionAncestorId":"D000008173", "ConditionAncestorTerm":"Lung Diseases, Obstructive" },{ "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012130", "ConditionAncestorTerm":"Respiratory Hypersensitivity" },{ "ConditionAncestorId":"D000006969", "ConditionAncestorTerm":"Hypersensitivity, Immediate" },{ "ConditionAncestorId":"D000006967", "ConditionAncestorTerm":"Hypersensitivity" },{ "ConditionAncestorId":"D000007154", "ConditionAncestorTerm":"Immune System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3137", "ConditionBrowseLeafName":"Asthma", "ConditionBrowseLeafAsFound":"Asthma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3840", "ConditionBrowseLeafName":"Bronchial Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9753", "ConditionBrowseLeafName":"Lung Diseases, Obstructive", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8601", "ConditionBrowseLeafName":"Hypersensitivity", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13550", "ConditionBrowseLeafName":"Respiratory Hypersensitivity", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8603", "ConditionBrowseLeafName":"Hypersensitivity, Immediate", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8783", "ConditionBrowseLeafName":"Immune System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"BC20", "ConditionBrowseBranchName":"Immune System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }