Allergic Rhinitis Due to Grass Pollen
Conditions
Brief summary
A national, multicenter, randmised double blind study with parallell arms. 360 patients with grass induced allergic rhinitis will be open randomised 1:2 to 3 years Grazax sublingual immunotherapy or 3 intralymphatic injections with ALK Alutard Timothy. In a second step, the ILIT group will be double blind randomised 1:1 to an intramuscular injection of Vitamin D Vicotrat or placebo, 4 week before the start of the intralymphatic treatment. The primary outcome measure is daily combined symptoms and medication scores during grass pollen season.
Interventions
DRUGSLIT Grazax ALK Nordic 75 000 SQ-T
Daily sublingual grass allergen tablets
DRUGILIT + Vitamin D
1 mL of Vicotrat D3, Heyl Pharma, 100 000 IU/mL, as intramuscular injection. Followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U/mL as three intralymphatic injections
DRUGILIT + placebo
1 ml of Sodium chloride solution 9 mg/mL as intramuscular injection followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U/mL as three intralymphatic injections
Sponsors
Lars Olaf Cardell
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 60 Years
Healthy volunteers
No
Inclusion criteria
* moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score \>/= 8. * informed consent
Exclusion criteria
* chronic rhinosinusitis with or without nose polyps * Previous immunotherapy (SLIT or SCIT) * BMI \> 35 * house dust mite allergy with symptoms * allergy towards furry animals if exposition cannot be avoided * 25(OH)Vitamin D levels \< 25 or \> 75 nmol/L * use of Vitamin D supplementation or excessive use of sun tanning booths * mental incapacity to follow study protocol * other significant disease * allergy towards study medication * uncontrolled asthma * severe atopic dermatitis * pregnancy or nursing * autoimmune disease * hyper IgE-syndrome * cardiovascular disease * lung disease * liver or kidney disease * hematologic disorder * metabolic disease * chronic infectious disese * medications interacting with the immune system * cancer * previous cytostatic therapy * medication with beta-blockers or ACE-inhibiters, if medication cannot be paused at the day for treatment * drug or alcohol abuse * intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1 * withdrawn consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSMS | 60-75 days at the grass pollen season year 1; 4 months before treatment. 60-75 days year 2; 6 months after start of treatment. | Daily Combined Symptoms and Medication Scores (0-3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CSMS peak pollen season | 15 days at the grass pollen season year 1; 4 months before treatment. 15 days year 2; 6 months after start of treatment. | Daily Combined Symptoms and Medication Scores (0-3) during the 15 consecutive days with the highest pollen count |
| RQLQ | 60-75 days at the grass pollen season year 1; 4 months before treatment. 60-75 days year 2; 6 months after start of treatment. | Juniper Rhinoconjunctivitis Quality of Life Questionnaire, weekly scores (0-28) |
| VAS (0-10) | 4-6 months before treatment and 6-9 months after treatment | Recalled symptoms severity at visual analogue scale |
| Serolology with immunoglobulins | 1 year before treatment, 4-6 weeks after treatment, 1 year after treatment | Total and grass specific levels of IgE, IgG, IgG4, IgA in serum |
Countries
Sweden
Contacts
Primary ContactAgneta Karlsson, Study nurse
Backup ContactLaila Hellkvist, MD, PhD
Outcome results
None listed