J30.3 H10.1 H10.8 J45.0
Conditions
Interventions
Group 1: Therapy allergen, LAIS Cat sublingual tablets or LAIS Cat oromucosal drops
Frequency of intake depends on the recommended by a doctor (3 times a week - daily intake)
Observation period of the AWB are one year as part of the regular medical visits.
Sponsors
Lofarma Deutschland GmbH
Eligibility
Sex/Gender
All
Age
5 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients can be included if they meet the following criteria: • Diagnosis of IgE-mediated allergic diseases of the immediate type, such as allergic rhinitis, allergic conjunctivitis (conjunctivitis) and allergic bronchial asthma, due to sensitization to cat epithelia is given, proven by standardized routine tests such as skin prick test, specific IgE or provocation: • The decision to initiate immunotherapy against cat allergy was made independently of and before inclusion in this NIS; Patients who have already started LAIS® cats treatment can be recruited, provided that all necessary baseline data can be taken from the medical record. (Due to the prospective design, the start of SIT with LAIS® cats should not be older than November 2020 for a study to be considered.) • Signed written informed consent. Parents (guardians) and the patient's consent are required for patients under 18 years of age. • The minimum age the doctor decides to put a patient on therapy is = 5 years.
Exclusion criteria
Exclusion criteria: Contraindications according to the current SmPC, including: • Malignant neoplastic diseases with current disease value. • Serious autoimmune diseases, immunodeficiency, immunodeficiency, immunosuppression. • Chronic inflammatory diseases. • Acute inflammation of the oral cavity with severe symptoms. • Moderate or severe uncontrolled bronchial asthma. • Illnesses in which the use of adrenaline is contraindicated (please note special warnings in the product information) • pregnancy. • Hypersensitivity to one of the "other ingredients" in the (see section 6.1 SmPC).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of the quality of life (RQLQ and VAS) b) Improvement of the rhinitic /rhinoconjunctival symptoms by means of R-CSMS and VAS c) Improvement of the bronchial / asthmatic symptoms by means of AA-CSMS and VAS | — |
Secondary
| Measure | Time frame |
|---|---|
| • Documentation of restrictions in daily life due to cat allergy (recording of impairment of quality of life), exposure to cats (household, friends; public environment), duration of treatment; reasons for treatment, switching or discontinuing therapy. • Characterization patterns of the application of LAIS® cats. • Characterization of the allergological diagnostics performed under routine conditions. • Comparison of the improvement of allergic symptoms/medications in the study period with different dosage schemes and / or pharmaceutical formulations (comparison between LAIS® cat drops vs LAIS® tablets). • Comparison of the improvement of allergic symptoms/medications in different age groups, between mono- vs. poly-sensitized patients, in relation to BMI and gender. • Documentation of the tolerability of the drug; collection of long-term safety data based on ADR documentation. • Examination of the adherence. If performed in routine clinical testing: comparison of allergological diagnostics (for cat allergens) before starting therapy and accompanying during therapy as an objective parameter for symptom severity (e.g. provocation or spirometry). | — |
Countries
Germany
Contacts
Public ContactVeronika Garus
Sacura GmbH
Outcome results
None listed