A prospective, non-interventional, multicenter observational study on quality of life, documentation of key allergic symptoms/medication and application patterns of SLIT LAIS® cat in patients with cat allergy.
- Conditions
- J30.3H10.1H10.8J45.0Other allergic rhinitisAcute atopic conjunctivitisOther conjunctivitisPredominantly allergic asthma
- Registration Number
- DRKS00025314
- Lead Sponsor
- ofarma Deutschland GmbH
- Brief Summary
The studied population exhibited improvements in quality of life and complaint profiles using RQLQ(S)-12-SA, RC-CSMS, visual scales, AA-CSMS, and asthma control assessment based on GINA criteria. There were 7 adverse drug reactions in total, with most patients having recovered during the study. There were no serious adverse drug reactions. The study was limited by its observational and exploratory design, smaller patient population than planned, and early termination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 111
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.
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).
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of the quality of life (RQLQ and VAS)<br>b) Improvement of the rhinitic /rhinoconjunctival symptoms by means of R-CSMS and VAS<br>c) Improvement of the bronchial / asthmatic symptoms by means of AA-CSMS and VAS
- Secondary Outcome Measures
Name Time Method