{
  "FullStudy":{
    "Rank":218015,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513837",
          "OrgStudyIdInfo":{
            "OrgStudyId":"SEPARALAT-1010-PII"
          },
          "Organization":{
            "OrgFullName":"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Rinitis y Sinusitis según la Gravedad Del Asma",
          "OfficialTitle":"PREVALENCIA, GRAVEDAD E IMPACTO DE LA RINITIS Y DE LA SINUSITIS SEGÚN EL NIVEL DE GRAVEDAD Y CONTROL DEL ASMA (PROYECTO IRIS-ASMA)",
          "Acronym":"IRIS-ASMA"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"March 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 7, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 10, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"José Antonio Castillo Vizuete",
            "ResponsiblePartyInvestigatorTitle":"MD",
            "ResponsiblePartyInvestigatorAffiliation":"Sociedad Española de Neumología y Cirugía Torácica"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Sociedad Española de Neumología y Cirugía Torácica",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"Based on the evidence for the \"common pathway\" in asthma presentation, our working hypothesis is that asthma severity and lack of control are related to the prevalence and severity of nasal and sinusal inflammatory pathology, and especially to chronic rhinosinusitis with nasal polyps.",
          "DetailedDescription":"Primary objective: To assess the prevalence and severity of rhinitis and rhinosinusitis, with or without nasal polyposis, in asthmatic patients depending on severity of their disease.\n\nSecondary objectives:\n\nTo assess the impact of nasal and sinusal pathology on asthma control.\n\nTo correlate asthma severity to rhinitis and rhinosinusitis.\n\nTo compare the potential association between chronic rhinosinusitis, with and without nasal polyposis, and asthma severity, and to detect radiographic differences, markers of atopy, and pulmonary function."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Asthma"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Only"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"450",
            "EnrollmentType":"Anticipated"
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients of both sexes aged 18‐70 years attending outpatient clinics diagnosed with asthma at least one year before. GINA/GEMA criteria will be used to diagnose asthma and to rate its severity.\n\nExclusion Criteria:\n\nIlliterate patients;\nvery severe, disabling comorbidity;\nprior non‐inflammatory nasosinusal disease",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Hospitals in Spain and Latin America",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Sociedad Española de Neumología y Cirugía Torácica (SEPAR)",
                "LocationCity":"Barcelona",
                "LocationState":"Catalonia",
                "LocationZip":"08029",
                "LocationCountry":"Spain"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000012852",
                "ConditionMeshTerm":"Sinusitis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010254",
                "ConditionAncestorTerm":"Paranasal Sinus Diseases"
              },{
                "ConditionAncestorId":"D000009668",
                "ConditionAncestorTerm":"Nose Diseases"
              },{
                "ConditionAncestorId":"D000012140",
                "ConditionAncestorTerm":"Respiratory Tract Diseases"
              },{
                "ConditionAncestorId":"D000012141",
                "ConditionAncestorTerm":"Respiratory Tract Infections"
              },{
                "ConditionAncestorId":"D000010038",
                "ConditionAncestorTerm":"Otorhinolaryngologic Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3137",
                "ConditionBrowseLeafName":"Asthma",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14240",
                "ConditionBrowseLeafName":"Sinusitis",
                "ConditionBrowseLeafAsFound":"Sinusitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M11750",
                "ConditionBrowseLeafName":"Paranasal Sinus Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11187",
                "ConditionBrowseLeafName":"Nose Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13561",
                "ConditionBrowseLeafName":"Respiratory Tract Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11544",
                "ConditionBrowseLeafName":"Otorhinolaryngologic 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"
              },{
                "ConditionBrowseBranchAbbrev":"BC09",
                "ConditionBrowseBranchName":"Ear, Nose, and Throat Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              }
            ]
          }
        }
      }
    }
  }
}