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

NCT03127436 | Completed

• 1 other identifier: Acarovac AT
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Safety and Tolerability - frequency and intensity of adverse events

  over the overall duration of the study

• Safety and Tolerability - local reactions at injection site

  over the overall duration of the study

• Safety and Tolerability - Number of systemic reactions

  over the overall duration of the study

• Changes in rhinoconjunctivitis score

  baseline and 3-6 month, depending on the intervals between the injections and the applied up-dosing scheme

Study Arms (1)

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.

Drug: Acarovac

Interventions

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.

Acarovac Hausstaubmilbe

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults, adolescents and children from the age of 5 on, who suffer from perenial allergic rhinoconjunctivitis causued by house dust mites.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Cologne: lead
• Bencard Allergie GmbH: collaborator

Study Sites (1)

Praxis für Lungenheilkunde

Vienna, 1230, Austria

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthias Kramer, Prof. Dr.

  Bencard Allergie GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Ralph Mösges

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 25, 2017
• Study Start: March 1, 2017
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)