Allergic rhinoconjunctivitis
Conditions
Sponsors
Allergy Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18-55 years. Seasonal moderate to severe allergic symptoms for grass and birch during the two latest seasons. Positive skin prick test and/or positive serum-IgE to birch and timothy. Retrospective symptoms measured as RTSS >= 8. Accepted and signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude the potential study patient from entry into the study and will exclude the patient for the ILIT injections at visits 3, 4 and 5: Pregnancy or nursing, or planning for that November 2017 until March 2018. Women with childbearing potential should use contraceptives. Condom only is not enough as contraceptive. Adequate anticonception: - Oral contraceptive, either combined or progestogen alone, - Injectable progestogen, - Implants or etenogestrel or levonogestrel, - Sterilisation done by the fertile woman, or male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject. a. Also, has practiced adequate contraception for 30 days prior to the first ILIT injection b. Has a negative pregnancy test on the day of vaccination c. Has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series. Autoimmune or collagen disease Known cardiovascular disease, i.e. not even NYHA class I. Use of ACE-blockers. If ACE-blockers are used, they should be withdrawn after discussion with the Principal Investigator 2 weeks before first injection until 2 weeks after last injection Pulmonary disease with FEV1 12% reversibility in FEV1 in visit 2. Concomitant infection with fever or other signs/symptoms of an acute or chronic infection at treatment. Allergic reaction last 3-4 days or anaphylaxia last month before ILIT injections. Vaccination of any kind two weeks before to two weeks after the three times of ILIT injections. Recent or on-going hepatic disease Recent or on-going renal disease All tumour diseases without non-melanoma skin cancers or in situ cervix cancer Increased bleeding tendency with or without abnormal platelets, PK-INR or APTT. Any other than study medication with an effect of interfering with the immune response Immuno- or chemotherapy last 15 years Upper airway disease (non-allergic sinusitis, nasal polyps) Depot steroid injection for treatment of allergic rhinoconjunctivitis Chronic obstructive or restrictive lung disease Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with beta-blockers) Major metabolic disease Known or suspected allergy to additives to the study product Skin diseases with barrier defect in the inguinal areas Alcohol, drug abuse or tobacco smoking Mental incapability of coping with the study Participation in another clinical study from visit one until last patient has been evaluated after the pollen season after treatment. Studies with pharmacological agents or studies that could otherwise disturb the study are not permitted after the first evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Symptoms and medicine consumption via the "Combined Symptom and Medication Score" (CSMS) that combines "Rhinoconjunctivitis Total Symptom Score" (RTSS) and the rhinitis "Medication Score" (MS). CSMS will be evaluated daily during the season before treatment and will be compared with the following pollen season after treatment and with placebo. The patients will use a mobile app for their responses. Effects on quality of Life (QoL), measured every other week for the season before the treatment and after the following pollen season using the "Rhinoconjunctivitis Quality of Life Questionnaire" (RQLQ).;Secondary Objective: Evaluation of the generic questionnaire,RAND-36, every other week during the pollen season before and after treatment. CDsens before treatment and during the autumn after treatment. Skin prick test reactions, specific IgE, inflammatory mediators and cell-mediated immunity in blood after the pollen season after treatment compared with pre-treatment. Safety variables: Registration of adverse events from the time of the first injection to 1 year after the last injection will be recorded for all patients. Also, control of Hb, leucocytes, differential count of leucocytes, transaminases and creatinine will be done before treatment and at the end of the study. After the placebo-controlled study is over in January 2019, we will continue follow the subjects in an open study for safety evaluation with a telephone call every year as well as the RQLQ questions for the two pollen seasons each year to 2015.;Primary end point(s): Symptoms and medicine consumption via a combined short questionnaire (CSMS) consisting of "Rhinoconjunctivitis Total Symptom Score" (RTSS) and use of rhinitis medication (MS) will be used via a daily electronic app and evaluated during the pollen season before treatment and compared with the the following pollen season after treatment. Effects on quality of life measured every second week during the pollen season | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A generic questionnaire, RAND-36, will be answered once a month during the two pollen seasons in the study. CDsens before and after treatment. Skin prick reactions, specific IgE och IgG4, inflammatory mediators and cel-mediated immunity in blood after the first and next pollen season after treatment compared with pre-treatment. Safety variables: Registration of adverse events from the time of the first injection to 1 year after the last injection has been given to all patients. Also, control of Hb, leucocytes, differential count of leucocytes, transaminases and creatinine wil be done before the treatment, after the treatment and at the end of the study. ;Timepoint(s) of evaluation of this end point: See above | — |
Countries
Sweden
Contacts
Public ContactLennart Nilsson
Allergy Centre
Outcome results
None listed