House dust mite allergy J30.3 J45
Conditions
Interventions
Group 1: Routine treatment with allergy immunotherapy with house dust mite allergens (Dermtophagoides pteronyssinus / farinae), Sublingual Immunotherapy-tablet (ACARIZAX, oral lyophilisate, 1 tablet d
Sponsors
ALK-Abelló Arzneimittel GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with at least one of the following conditions: ? Persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication. ? House dust mite allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe house dust mite allergic rhinitis; age: 18-65 years; no contraindication to a prescription of ACARIZAX®
Exclusion criteria
Exclusion criteria: Contraindications according to ACARIZAX SmPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events (AE) / Adverse Drug Reactions (ADR) / Serious Adverse Events (SAE) during 10 to 12 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Allergy symptoms (physicians assessment: score 0-3 / use of symptomatic medication, level of asthma control (acc. to GINA 2015) during 5 visits with approx. 3 month intervals | — |
Countries
Germany
Contacts
Public ContactHendrik Wolf
ALK-Abelló Arzneimittel GmbH, Clinical Development
Outcome results
None listed