Rhinitis, Allergic
Conditions
Brief summary
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.
Detailed description
38 patients with seasonal allergic rhinitis that have recently (within 20 months) ended a full subcutaneous immunotherapy protocol with birch or grass allergen with improvement but not full symptom relief are recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch.
Interventions
3 injections with 4-5 weeks interval.
DRUGALK diluent
0,3% human albumin
Sponsors
Karolinska University Hospital
Skane University Hospital
Sodra Alvsborgs 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
* Age 18-55 * Accepted and signed informed consent. * Recently (within 20 months) ended a full 3 year program with subcutaneous immunotherapy (SCIT) with amelioration of symptoms but not full symptom relief.
Exclusion criteria
* Previously subcutaneous immunotherapy (SCIT) with total symptom relief. * Previously SCIT but no symptom improvement at all. * Sensitizations to house dust mite or furry animals, with symptoms. * Severe atopic dermatitis. * Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study. * Patients with a respiratory tract infection in the past 4 weeks prior to Visit 2. * Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants). * Known autoimmune or collagen disease * Cardiovascular disease * Perennial pulmonary disease including asthma * Hepatic disease * Known renal insufficiency * Cancer * Hematologic disease * Chronic infectious disease * Any medication with a possible side-effect of interfering with the immune response * Previous immuno- or chemotherapy, apart from SCIT * 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 * Obesity with BMI \> 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection. * Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit 1. * Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit 1. * Mental incapability of coping with the study * Withdrawal of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total daily symptoms and medications score | 5-7 months after treatment | Difference between active and placebo group in total daily symptoms and medications score during the pollen season. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin prick test reactivity | 4-8 weeks after treatment, 9-12 months after treatment | Tested with ALK Soluprick. Measured as the wheal area in millimeter for birch- or grass pollen. |
| Change in symptoms score after nasal allergen challenge | 4-8 weeks after treatment, 9-12 months after treatment | 0,1 ml of ALK Aquagen Birch or Timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded. |
| Difference between active and placebo group in Quality of Life measured with Juniper Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | Up to 7 months after treatment. | At peak pollen season after treatment. |
| Improvement on Visual Analogue Scale (VAS) | During pollen season and recalled after pollen season, approximately 1 year after the start of treatment. | Difference in improvement on VAS between active and placebo group. |
| Change in allergen specific S- antibody levels. | 4-8 weeks after treatment, 9-12 months after treatment | IgE, IgG, IgG4 |
| Incidence of adverse events graded as mild-moderate-severe | From first injection to 30 days after last injection. | — |
| Difference between active and placebo group in Quality of Life measured with Sino Nasal Outcome Test -22 (SNOT-22) | Up to 7 months after treatment. | At peak pollen season after treatment. |
Countries
Sweden
Outcome results
None listed