[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520844":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":29,"studyPopulation":29,"armGroups":41,"interventions":58,"overallOfficials":74,"centralContacts":78,"locations":88,"responsibleParty":132,"collaborators":29,"id":136,"slug":29,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":137,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":29,"studyType":148,"phases":149,"briefSummary":152,"conditions":153,"keywords":29,"overallStatus":119,"whyStopped":29,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"CSMS","Daily Combined Symptoms and Medication Scores (0-3)","60-75 days at the grass pollen season year 1; 4 months before treatment. 60-75 days year 2; 6 months after start of treatment.",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"CSMS peak pollen season","Daily Combined Symptoms and Medication Scores (0-3) during the 15 consecutive days with the highest pollen count","15 days at the grass pollen season year 1; 4 months before treatment. 15 days year 2; 6 months after start of treatment.",{"measure":19,"description":20,"timeFrame":12},"RQLQ","Juniper Rhinoconjunctivitis Quality of Life Questionnaire, weekly scores (0-28)",{"measure":22,"description":23,"timeFrame":24},"VAS (0-10)","Recalled symptoms severity at visual analogue scale","4-6 months before treatment and 6-9 months after treatment",{"measure":26,"description":27,"timeFrame":28},"Serolology with immunoglobulins","Total and grass specific levels of IgE, IgG, IgG4, IgA in serum","1 year before treatment, 4-6 weeks after treatment, 1 year after treatment",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":36},"QUADRUPLE",[37,38,39,40],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[42,48,53],{"label":43,"type":44,"description":45,"interventionNames":46},"SLIT","ACTIVE_COMPARATOR","Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years",[47],"Drug: SLIT Grazax ALK Nordic 75 000 SQ-T",{"label":49,"type":44,"description":50,"interventionNames":51},"ILIT + Vitamin D","Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.",[52],"Drug: ILIT + Vitamin D",{"label":54,"type":44,"description":55,"interventionNames":56},"ILIT + placebo","Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.",[57],"Drug: ILIT + placebo",[59,64,69],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":29},"DRUG","SLIT Grazax ALK Nordic 75 000 SQ-T","Daily sublingual grass allergen tablets",[43],{"type":60,"name":49,"description":65,"armGroupLabels":66,"otherNames":67},"1 mL of Vicotrat D3, Heyl Pharma, 100 000 IU\u002FmL, as intramuscular injection. Followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U\u002FmL as three intralymphatic injections",[49],[68],"Alutard SQ timothy and Vicotrat D3",{"type":60,"name":54,"description":70,"armGroupLabels":71,"otherNames":72},"1 ml of Sodium chloride solution 9 mg\u002FmL as intramuscular injection followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U\u002FmL as three intralymphatic injections",[54],[73],"Alutard SQ timothy and Sodium chloride",[75],{"name":76,"affiliation":5,"role":77},"Lars O Cardell, Professor","PRINCIPAL_INVESTIGATOR",[79,84],{"name":80,"role":81,"phone":82,"phoneExt":29,"email":83},"Agneta Karlsson, Study nurse","CONTACT","+46 72 580 29 63","agneta.j.karlsson@regionstockholm.se",{"name":85,"role":81,"phone":86,"phoneExt":29,"email":87},"Laila Hellkvist, MD, PhD","+46 72 469 46 07","laila.hellkvist@regionstockholm.se",[89,105,117],{"facility":90,"status":91,"city":92,"state":29,"zip":29,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Skåne University Hospital, ENT department","NOT_YET_RECRUITING","Lund","Sweden","SE",{"type":96,"coordinates":97},"Point",[98,99],13.19321,55.70584,{"lat":99,"lon":98},[102],{"name":103,"role":81,"phone":29,"phoneExt":29,"email":104},"Franziska Nordström, MD","franziska.nordstrom@skane.se",{"facility":106,"status":91,"city":107,"state":29,"zip":29,"country":93,"countryCode":94,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Örebro University Hospital","Örebro",{"type":96,"coordinates":109},[110,111],15.2066,59.27412,{"lat":111,"lon":110},[114],{"name":115,"role":81,"phone":29,"phoneExt":29,"email":116},"Amanj Saber, MD","amanj.saber@regionorebrolan.se",{"facility":118,"status":119,"city":120,"state":29,"zip":29,"country":93,"countryCode":94,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Karolinska University Hospital, ENT-department","RECRUITING","Stockholm",{"type":96,"coordinates":122},[123,124],18.06871,59.32938,{"lat":124,"lon":123},[127,131],{"name":128,"role":81,"phone":129,"phoneExt":29,"email":130},"Eirini Paziou, MD","+46 8 123 723 96","eirini.paziou@regionstockholm.se",{"name":85,"role":81,"phone":86,"phoneExt":29,"email":87},{"type":133,"investigatorFullName":134,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Lars Olaf Cardell","Professor","100520844",false,"NCT06061848","Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT","ILIT vs SLIT","Inclusion Criteria:\n\n* moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score \\>\u002F= 8.\n* informed consent\n\nExclusion Criteria:\n\n* chronic rhinosinusitis with or without nose polyps\n* Previous immunotherapy (SLIT or SCIT)\n* BMI \\> 35\n* house dust mite allergy with symptoms\n* allergy towards furry animals if exposition cannot be avoided\n* 25(OH)Vitamin D levels \\\u003C 25 or \\> 75 nmol\u002FL\n* use of Vitamin D supplementation or excessive use of sun tanning booths\n* mental incapacity to follow study protocol\n* other significant disease\n* allergy towards study medication\n* uncontrolled asthma\n* severe atopic dermatitis\n* pregnancy or nursing\n* autoimmune disease\n* hyper IgE-syndrome\n* cardiovascular disease\n* lung disease\n* liver or kidney disease\n* hematologic disorder\n* metabolic disease\n* chronic infectious disese\n* medications interacting with the immune system\n* cancer\n* previous cytostatic therapy\n* medication with beta-blockers or ACE-inhibiters, if medication cannot be paused at the day for treatment\n* drug or alcohol abuse\n* intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1\n* withdrawn consent\n\nExclusion Criteria only for ILIT group (due to vitamin D treatment)\n\n* medication witch can interacts with vitD: (ACE-inhibitors, antiepileptic drugs, glycosides, orlistat, statines, thiazide diuretics)\n* tendency for formation of kidney stones\n* hyperparathyroidism or other disease conferring risk of hypercalcemia\n* hereditary pseudohypoparathyroidism with decreased phosphorous secretion\n* malabsorption or bowel disease with diarrhea\n* Mb Paget, osteoporosis or sarcoidosis\n* skin disease at the groin (where the treatment will be injected)","ALL","18 Years","60 Years",{"count":146,"type":147},360,"ESTIMATED","INTERVENTIONAL",[150,151],"PHASE2","PHASE3","A national, multicenter, randmised double blind study with parallell arms. 360 patients with grass induced allergic rhinitis will be open randomised 1:2 to 3 years Grazax sublingual immunotherapy or 3 intralymphatic injections with ALK Alutard Timothy. In a second step, the ILIT group will be double blind randomised 1:1 to an intramuscular injection of Vitamin D Vicotrat or placebo, 4 week before the start of the intralymphatic treatment. The primary outcome measure is daily combined symptoms and medication scores during grass pollen season.",[154],"Allergic Rhinitis Due to Grass Pollen","2024-10-17",{"date":157,"type":158},"2024-10-21","ACTUAL",{"date":160,"type":158},"2023-02-01",{"date":162,"type":147},"2031-12-28",{"name":134,"class":6},3]