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

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: Acarovac

• Registration Number: NCT03127436
• Lead Sponsor: University Hospital of Cologne

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Primary Completion: 2019-02-14
• Study Completion: 2019-02-14
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acarovac Hausstaubmilbe	Acarovac	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.

Primary Outcome Measures

Name	Time	Method
Numbers of treatment-related local and systemic reactions following SCIT administration	over the overall duration of the study	Tolerability and safety will be assessed by the frequency and intensity of local reactions at the injection site (wheal size 5-10 cm, \> 10 cm ) and systemic reactions (skin, airways, others) through study completion.; The study covers the four injections of the up-dosing phase and one injection of the maintenance phase of the immunotherapy course.

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability - local reactions at injection site	over the overall duration of the study	Frequency and intensity of local reactions at the injection site (wheal size 5-10 cm, \> 10 cm )
Safety and Tolerability - frequency and intensity of adverse events	over the overall duration of the study	Frequency and intensity of adverse events
Safety and Tolerability - Number of systemic reactions	over the overall duration of the study	Frequency and intensity of systemic reactions
Changes in rhinoconjunctivitis score	baseline and 3-6 month, depending on the intervals between the injections and the applied up-dosing scheme	The rhinoconjunctivitis score combines rhinitis symptom intensity and conjunctivitis symptom intensity and will be assessed retrospectively and after the course of treatment

Trial Locations

Locations (1)

Praxis für Lungenheilkunde; 🇦🇹 Wien, Austria