Prospective, multi-centre, non-interventional safety trial to collect real-world data on the safety of immunotherapy with Depigoid® Katze in patients with allergic rhinitis/rhino-conjunctivitis with or without controlled asthma due to feline epithelia

• Conditions: allergic rhinitis/rhino-conjunctivitis with or without controlled asthma due to feline epithelia; J30.3; H10.1; H10.8; Other allergic rhinitis; Acute atopic conjunctivitis; Other conjunctivitis

• Registration Number: DRKS00028182
• Lead Sponsor: ETI Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-14
• Study Completion: 2024-04-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Patients aged = 12 years suffering from persistent moderate to severe allergic rhinitis and/or rhino-conjunctivitis with or without controlled asthma caused by clinically relevant sensitisation to cats, demonstrated by a positive skin prick test (wheal diameter = 3 mm) for Felix domesticus animal epithelia.
The patients have an indication for subcutaneous immunotherapy based on their symptoms and findings and, together with their doctor, chose treatment with Depigoid® Katze in accordance with standard clinical practice.
The patients have understood and signed the declaration of consent form for participation and use of patient-related data in this non-interventional safety study.
Concomitant asthma must be under control and stable as per the guidelines in the SmPC (no exacerbations within 3 months prior to inclusion in the study).

Exclusion Criteria

not applicable

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Number and severity of systemic reactions (World Allergy Organisation criteria)<br>- Number and severity of local reactions <br>- Onset of systemic and/or local reaction (immediate or late phase)<br>

Secondary Outcome Measures

Name	Time	Method
- Comparison of two up-dosing regimens (Conventional up-dosing versus Quick up-dosing) with regard to the primary variables<br>- Comparison of conventional up-dosing and Quick up-dosing in terms of the proportion of patients reaching the maintenance treatment phase.<br>- Comparison of conventional up-dosing and Quick up-dosing with regard to the proportion of patients with local or systemic reactions.<br>- Quality of life progression determined using the SF-12 questionnaire (assessment period: 1 week)<br>