Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe

University Hospital of Cologne

Status: Completed

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: Acarovac

Study type: Observational

Funder types: Other

Identifiers

NCT03127436

Acarovac AT

Details and patient eligibility

About

Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT therapy With Acarovac® Hausstaubmilbe

Full description

This prospective open multi-centre non-interventional study was initiated to document the tolerability and the safety profile of the subcutaneous allergen-specific immunotherapy with Acarovac® in house dust mite allergic patients in routine medical care.

During the up-dosing phase with Acarovac®, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval.

Data on tolerability are documented by the physicians.

Enrollment: 32 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of the age of 5 years and older suffering from a house dust mite induced allergic rhinitis

Exclusion criteria

• Patients suffering from acute or chronic infections or inflammations
• Patients suffering from secondary modifications of the target organ with function impairment (emphysema, bronchiectasis)
• Patients suffering from severe and uncontrolled asthma
• Patients with a known severe autoimmune disease
• Patients with active malignant disease
• Patients requiring beta-blockers
• Patients having any contraindication for the use of adrenaline
• Patients with a hypersensitivity to the excipients of the drug

Trial design

32 participants in 1 patient group

Acarovac Hausstaubmilbe

Description:

This prospective open multi-centre non-interventional study was initiated to document the tolerability and the safety profile of the subcutaneous allergen-specific immunotherapy with Acarovac in house dust mite allergic patients (children and adults) in routine medical care. During the up-dosing phase with Acarovac, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval. Data on tolerability are documented by the physicians.

Treatment:

Drug: Acarovac