{
  "FullStudy":{
    "Rank":217907,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515280",
          "OrgStudyIdInfo":{
            "OrgStudyId":"11112011"
          },
          "Organization":{
            "OrgFullName":"Hull University Teaching Hospitals NHS Trust",
            "OrgClass":"OTHER_GOV"
          },
          "BriefTitle":"Hull Airway Reflux Questionnaire Scores Following Cough Treatment",
          "OfficialTitle":"Supplementary Study of Hull Airway Reflux Questionnaire Scores Before and After Treatment Study: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough.\""
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 11, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 15, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Hull University Teaching Hospitals NHS Trust",
            "LeadSponsorClass":"OTHER_GOV"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The aim of this study is to have those patients taking part in the Clinical trial-: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough. Complete the Hull Airway Reflux Questionnaire (HARQ) at randomisation and repeat the questionnaire at the end of the 14 day treatment period. The investigators hope to demonstrate a clinically significant change in HARQ scores of at least 16 points from before and after treatment. Furthermore the investigators would hope to show a significantly improved HARQ score in patients on the BC036 arm of the study compared to the placebo arm."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Cough"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "chronic cough"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "PatientRegistry":"No",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Only"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Cross-Sectional"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"57",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Chronic cough",
                "ArmGroupDescription":"Patients taking part in supplementary study must be randomised to main study which includes a placebo arm and treatment arm"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Hull Airway Reflux Questionnaire score",
                "PrimaryOutcomeDescription":"The primary objective is to evaluate the effectiveness of HARQ in measuring a clinically significant change in HARQ score from baseline following 14 days treatment.",
                "PrimaryOutcomeTimeFrame":"baseline and 2 weeks later"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"HARQ SCORES",
                "SecondaryOutcomeDescription":"The Key secondary endpoint will be to evaluate ability of HARQ in demonstrating a clinically significant change in score from baseline in the BC036 arm compared to Placebo arm of main study.",
                "SecondaryOutcomeTimeFrame":"baseline and 14 days"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMale/females meeting eligibility criteria for study: - A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough.\nWilling and able to comply with study procedures\nAble to provide written informed consent to participate\n\nExclusion Criteria:\n\n1. Any subject meeting any exclusion criteria on the study \"A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough.\" Will be excluded from this study.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"75 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"patients attending chronic cough clinics",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Alyn H Morice, MD, Mphil",
                "OverallOfficialAffiliation":"Hull and EastYorkshire NHS Trust",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Hull and East Yorkshire Hospitals Trust",
                "LocationCity":"Cottingham",
                "LocationState":"East Riding Of Yorkshire",
                "LocationZip":"HU16 5JQ",
                "LocationCountry":"United Kingdom"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"28839984",
                "ReferenceType":"result",
                "ReferenceCitation":"Morice AH, McGarvey L, Pavord ID, Higgins B, Chung KF, Birring SS. Theobromine for the treatment of persistent cough: a randomised, multicentre, double-blind, placebo-controlled clinical trial. J Thorac Dis. 2017 Jul;9(7):1864-1872. doi: 10.21037/jtd.2017.06.18."
              }
            ]
          },
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Publication Link",
                "SeeAlsoLinkURL":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5542984/"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003371",
                "ConditionMeshTerm":"Cough"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012120",
                "ConditionAncestorTerm":"Respiration Disorders"
              },{
                "ConditionAncestorId":"D000012140",
                "ConditionAncestorTerm":"Respiratory Tract Diseases"
              },{
                "ConditionAncestorId":"D000012818",
                "ConditionAncestorTerm":"Signs and Symptoms, Respiratory"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5173",
                "ConditionBrowseLeafName":"Cough",
                "ConditionBrowseLeafAsFound":"Cough",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M7463",
                "ConditionBrowseLeafName":"Gastroesophageal Reflux",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13540",
                "ConditionBrowseLeafName":"Respiration Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14206",
                "ConditionBrowseLeafName":"Signs and Symptoms, Respiratory",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC08",
                "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              }
            ]
          }
        }
      }
    }
  }
}