Rhinitis, Allergic, Seasonal
Conditions
Keywords
Hay fever, Pollen allergy, Allergic rhinitis
Brief summary
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo. \*\*\*IMPORTANT INFORMATION!\*\*\* The up-dosing protocol is changed due to adverse events at 5000 SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.
Detailed description
40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval.
Interventions
DRUGALK Diluent
DRUGALK Alutard SQ 5-grasses or ALK Alutard Birch
Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension.
Sponsors
Skane University Hospital
Karolinska University Hospital
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Seasonal allergic symptoms for birch and/or grass verified by skin prick test, * Accepted informed consent
Exclusion criteria
* Pregnancy or nursing * Autoimmune or collagen disease (known) * Cardiovascular disease * Perennial pulmonary disease * Hepatic disease * Renal disease * Cancer * Any medication with a possible side-effect of interfering with the immune response * Previous immuno- or chemotherapy * Chronic diseases * Other 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 β-blockers) * Major metabolic disease * Known or suspected allergy to the study product * Alcohol or drug abuse * Mental incapability of coping with the study * Withdrawal of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean combined daily symptoms-and-medications-score | Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment). | Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) and medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean total daily medications score | Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment). | Daily scoring of medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids). |
| Change in subjective allergic symptoms following nasal allergen provocation | Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment. | The study subjects will be intranasally challenged with allergen and symptom score questionnaires are filled out pre-provocation and 5, 10 and 30 min post-provocation. |
| Effects on quality of life | During peak pollen season which will be up to 6 months after completed treatment. | Juniper Rhinitis quality of life questionnaire (RQLQ) questionnaires |
| Mean total daily symptoms score | Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment). | Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) |
| S-IgE Grass or Birch | Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment | — |
| S-IgG4 Grass or Birch | Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment | — |
| Registration of adverse event | From the first injection to 30 days after the last injections has been given | — |
| Short term change of skin reactivity | Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment. | Skin prick test |
Countries
Sweden
Outcome results
None listed