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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 14, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Acarovac Hausstaubmilbe
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Numbers of treatment-related local and systemic reactions following SCIT administration
    • Time Frame: 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 Measures

  • Safety and Tolerability – frequency and intensity of adverse events
    • Time Frame: over the overall duration of the study
    • Frequency and intensity of adverse events
  • Safety and Tolerability – local reactions at injection site
    • Time Frame: 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 – Number of systemic reactions
    • Time Frame: over the overall duration of the study
    • Frequency and intensity of systemic reactions
  • Changes in rhinoconjunctivitis score
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital of Cologne
  • Collaborator
    • Bencard Allergie GmbH
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. Ralph Mösges, Prof. Dr. med. Ralph Mösges – University Hospital of Cologne
  • Overall Official(s)
    • Matthias Kramer, Prof. Dr., Study Director, Bencard Allergie GmbH

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