Allergic Rhinitis
Conditions
Keywords
House Dust Mite, allergy, rhinitis, asthma
Brief summary
The primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in adult subjects with moderate to severe HDM allergic rhinitis.
Interventions
BIOLOGICALSLITone ULTRA HDM immunotherapy
Sponsors
ALK-Abelló A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 or older * Moderate to severe persistent HDM allergic rhinitis with or without asthma * Moderate to severe HDM allergic rhinitis symptoms during a baseline period * Positive skin prick test response (wheal diameter ≥ 3 mm) * Positive specific IgE ≥ IgE Class 2, ≥ 0.70 kU/l)
Exclusion criteria
* Previous treatment with immunotherapy with House dust mite immunotherapy * Ongoing treatment with any allergen specific immunotherapy product * Reduced lung function * Clinical history of uncontrolled asthma * Inflammatory conditions in the oral cavity with severe symptoms * History of anaphylaxis with cardiorespiratory symptoms * History of recurrent generalised urticaria * A history of drug induced facial angioedema or hereditary angiooedema * Any clinically relevant chronic disease (≥3 months duration) * Systemic disease affecting the immune system * Immunosuppressive treatment * Currently treated with tricyclic antidepressants; catecholamine-Methyltransferase inhibitors and mono amine oxidase inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in IgE-blocking factor after 6 months of treatment | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with treatment related adverse events | 6 months |
Countries
France
Outcome results
None listed