Trials Sponsors Conditions Drugs Pricing

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

AcarovacDrug

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age5 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability 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

Sponsors & Collaborators

Bencard Allergie GmbH
Othercollaborator
University Hospital of Cologne
Otherlead

Study Sites (1)

Praxis für Lungenheilkunde

Vienna, 1230, Austria

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Matthias Kramer, Prof. Dr.
Bencard Allergie GmbH
STUDY DIRECTOR

Enrollment

32 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Acarovac Hausstaubmilbe

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Acarovac Hausstaubmilbe

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations