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

Perennial Allergic Rhinitis Clinical Trial

Official title:

A Prospective, Open, Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe in Patients With HDM-induced Rhinoconjunctivitis With or Without Allergic Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127436
• Other study ID #: Acarovac AT
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: February 14, 2019

Study information

• Verified date: April 2019
• Source: University Hospital of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT therapy With 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 14, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Acarovac
House dust mite sensitized Patients receive increasing doses of subcutaneous immunotherapy with Acarovac. During the up-dosing phase, 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.

Locations

Country	Name	City	State
Austria	Praxis für Lungenheilkunde	Wien

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Cologne	Bencard Allergie GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of treatment-related local and systemic reactions following SCIT administration	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.	over the overall duration of the study
Secondary	Safety and Tolerability - frequency and intensity of adverse events	Frequency and intensity of adverse events	over the overall duration of the study
Secondary	Safety and Tolerability - local reactions at injection site	Frequency and intensity of local reactions at the injection site (wheal size 5-10 cm, > 10 cm )	over the overall duration of the study
Secondary	Safety and Tolerability - Number of systemic reactions	Frequency and intensity of systemic reactions	over the overall duration of the study
Secondary	Changes in rhinoconjunctivitis score	The rhinoconjunctivitis score combines rhinitis symptom intensity and conjunctivitis symptom intensity and will be assessed retrospectively and after the course of treatment	baseline and 3-6 month, depending on the intervals between the injections and the applied up-dosing scheme