Skip to main content
OpenTrials
Completed

NCT Number: NCT03127436

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Perennial Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxis für Lungenheilkunde

Vienna, 1230, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acarovac

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. Safety and Tolerability - frequency and intensity of adverse events

    Time frame: over the overall duration of the study

    Frequency and intensity of adverse events

  2. 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 )

  3. Safety and Tolerability - Number of systemic reactions

    Time frame: over the overall duration of the study

    Frequency and intensity of systemic reactions

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital of Cologne

Other

Collaborators

  • Bencard Allergie GmbH

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 25, 2017
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.