Allergic rhinoconjunctivitis
Conditions
Sponsors
Allergy Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18-55 years, Seasonal allergic symptoms for grass and birch during the two latest seasons Positive skin prick test to birch and grass. 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 66 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 2014 until mars 2015. 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 Autoimmune or collagen disease Known cardiovascular disease, i.e. not even NYHA class I. ACE-blockers withdrawn after discussion with the Principal Investigator 2 weeks before first injection until 2 weeks after last injection Pulmonary disease with FEV1 15% reversibility in FEV1 in visit 2. Concomitant infection with fever or other signs/symptoms of an acute or chronic infection vid behandling. Allergic reaction last 3-4 days or anaphylaxia last month before ILIT injections. Vaccination of any kind one month before to one month 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. Thereafter, 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 "Rhinoconjunctivitis Total Symptom Score" (RTSS) and use of rhinitis medications (MS) will be evaluated during the season before treatment and compared with the three following pollen seasons. The RTSS and medication score will be answered by the patients at the end of the birch pollen season and at the end of the grass pollen season. ;Secondary Objective: Symptoms following conjunctival allergen provocation before treatment compared to two months after the end of the first and third season after treatment. Effects on quality of life (QoL), measured for the season before the treatment and after the three following pollen seasons using the "Rhinoconjunctivitis Quality of Life Questionnaire" (RQLQ). Skin prick reactions, specific IgE, inflammatory mediators and cell-mediated immunity in blood after the first and third pollen seasons after treatment compared with pretreatment. 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 will be done before the treatment, after the treatment and at the end of the study. ;Primary end point(s): Symptoms and medicine consumption via "Rhinoconjunctivitis Total Symptom Score" (RTSS) and use of rhinitis medications (MS) will be evaluated during the season before treatment and compared with the three following pollen seasons. The RTSS and medication score will be answered by the patients at the end of the birch pollen season and at the end of the grass pollen season.;Timepoint(s) of evaluation of this end point: See above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Symptoms following conjunctival allergen provocation before treatment compared to two months after the end of the first and third season after treatment. Effects on quality of life (QoL), measured for the season before the treatment and after the three following pollen seasons using the "Rhinoconjunctivitis Quality of Life Questionnaire" (RQLQ). Skin prick reactions, specific IgE, inflammatory mediators and cell-mediated immunity in blood after the first and third pollen seasons after treatment compared with pretreatment. 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 will 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