Allergic rhinoconjunctivitis MedDRA version: 15.0 Level: PT Classification code 10048908 Term: Seasonal allergy System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: ALK-Alutard SQ Betula verrucosa®
Pharmaceutical Form: Injection
Trade Name: ALK-alutard SQ 5-grasses®
Pharmaceutical Form: Injection
Sponsors
Allergy Centre, University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Age 18-50 years, Seasonal allergic symptoms for grass or birch verified by skin prick test. 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: The presence of any of the following will exclude the potential study patient from entry into the study: Pregnancy or nursing, or planning for that. Women with childbearing potential should use contraceptives. Condom only is not enough as contraceptive. Autoimmune or collagen disease Grave cardiovascular disease, milder cases decided by the investigator Perennial pulmonary disease, FEV1 < 80 % of predicted, or use of more then 400 microgram budesonide (or equivalent/day) Recent or on-going hepatic disease Recent or on-going renal disease Cancer – as decided by the investigator Any medication with a possible side effect of interfering with the immune response, Previous immuno- or chemotherapy Upper airway disease (non-allergic sinusitis, nasal polyps) Chronic obstructive and 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 for addatives in the study product Alcohol or drug abuse Mental incapability of coping with the study Participation in another clinical study within 30 days that could jeopardize this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effect on subjective symptoms following conjunctival allergen provocation before treatment compared to two months after the end of the first season.;Secondary Objective: Efficacy variables • Effects on quality of life (QoL), measured retrospectively, for the season before the treatment and after the three following pollen seasons using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). • Symptoms and medicine consumption via Rhinoconjunctivitis Total Symptom Score (RTSS) before treatment and after the three following pollen seasons. • Skin prick reactions, specific IgE, inflammatory mediators and cellmediated immunity in blood after the following three pollen seasons compared to pretreatment. • Effects on subjective symptom and use of conventional rhinitis medication after the 1st, 2nd and 3rd grass pollen season and conjunctival provocation test after the 1st and 3rd pollen seasons. Safety variables: Registration of adverse events from the time of the first injection to 1 year after the last injection has been given in all patients. Control of Hb, leucocytes, differential count of leucocytes, transaminases and creatinine.;Primary end point(s): Effect on subjective symptoms following conjunctival allergen provocation before treatment compared to two months after the end of the first season.;Timepoint(s) of evaluation of this end point: 1-2 months after the pollen season 2013. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy variables • Effects on quality of life (QoL), measured retrospectively, for the season before the treatment and after the three following pollen seasons using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). • Symptoms and medicine consumption via Rhinoconjunctivitis Total Symptom Score (RTSS) before treatment and after the three following pollen seasons. Also, control of Hb, leucocytes, differential count of leucocytes, transaminases and creatinine. • Skin prick reactions, specific IgE, inflammatory mediators and cellmediated immunity in blood after the following three pollen seasons compared to pretreatment. • Effects on subjective symptom and use of conventional rhinitis medication after the 1st, 2nd and 3rd grass pollen season and conjunctival provocation test after the 1st and 3rd pollen seasons. Safety variables: Registration of adverse events from the time of the first injection to 1 year after the last injection has been given in all patients.;Timepoint(s) of evaluation of this end point: The evaluations of endpoints are 1-2 months after the first, second and third pollen seasons. | — |
Countries
Sweden
Contacts
Public ContactLennart Nilsson
Allergy Centre, University Hospital
Outcome results
None listed