Clinical trial NCT03127436: Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perennial Allergic Rhinitis
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
Collaborators: name: Bencard Allergie GmbH
First posted: 2017-04-25
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numbers of treatment-related local and systemic reactions following SCIT administration
timeFrame: over the overall duration of the study
Secondary outcomes:
measure: Safety and Tolerability - frequency and intensity of adverse events
timeFrame: over the overall duration of the study
measure: Safety and Tolerability - local reactions at injection site
timeFrame: over the overall duration of the study
measure: Safety and Tolerability - Number of systemic reactions
timeFrame: over the overall duration of the study
measure: Changes in rhinoconjunctivitis score
timeFrame: baseline and 3-6 month, depending on the intervals between the injections and the applied up-dosing scheme
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Praxis für Lungenheilkunde
Study officials:
affiliation: Bencard Allergie GmbH
name: Matthias Kramer, Prof. Dr.
role: STUDY_DIRECTOR
References: