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

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 - LETI MIAU-KAT 2022

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00028182

Enrollment

400

Registered

2022-03-14

Start date

2022-05-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic rhinitis/rhino-conjunctivitis with or without controlled asthma due to feline epithelia J30.3 H10.1 H10.8

Interventions

Group 1: Patients suffering from persistent moderate to severe allergic rhinitis and/or rhinoconjunctivitis with or without controlled asthma caused by clinically relevant sensitisation to cats, demon

Eligibility

Sex/Gender

All

Age

12 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: not applicable

Design outcomes

Primary

Measure	Time frame
- Number and severity of systemic reactions (World Allergy Organisation criteria) - Number and severity of local reactions - Onset of systemic and/or local reaction (immediate or late phase)	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactEdmund Curtius

ClinCompetence Cologne GmbH

edmund.curtius@ClinCompetence.de+49 221 7161 330

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026