Clinical trial NCT02553590: Tolerability of SLIT With LAIS® 2-Tree Allergoid Tablets
Official title: Non-Interventional Study (NIS) on the Tolerability of Sublingual Immunotherapy With LAIS® 2-Tree Tablets in Consideration of the Chosen Titration Schedule in Everyday Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Keywords: Non Interventional Study
NIS
sublingual immunotherapy
allergen
tree
birch
alder
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 160
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 5 years or older can be enrolled in the NIS if sublingual specific immunotherapy has been indicated due to allergic rhinoconjunctivitis or allergic bronchial asthma induced by the allergens to be investigated (birch and/or alder).

Brief summary: To expand knowledge on the application and tolerability of immunotherapy with LAIS® 2-tree allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual therapy in special consideration of the chosen titration schedule in everyday practice.

Detailed description: Until now, results from controlled studies with their specific requirements (patient selection, defined inclusion and exclusion criteria, close patient management and monitoring, randomisation) are available for LAIS® 2-tree allergoid tablets only for a small patient population. In addition, an open-label, controlled study and an observational study have been carried out investigating the clinical efficacy and tolerability of the preparation. Owing to the differences in the study designs, the allergen dose administered and the frequency with which the preparation was applied varied among the individual studies, making it necessary to gather further data on the safety and tolerability of the preparation in a larger patient population.

The observation schedule of this NIS (NIS in accordance with Article 67 Paragraph 6 of the German Medicinal Products Act (AMG)), which takes into account the recommendations made by the German Federal Institute for Drugs and Medical Devices (BfArM) and by the Paul Ehrlich Institute for planning, implementing and evaluating an NIS, is geared to the routine procedure carried out for patients with allergies to tree pollen.

The aim of this observational study is to observe and document the tolerability and improvement of symptoms after treatment with LAIS® 2-tree allergoid tablets under normal application conditions and in consideration of the chosen titration schedule in therapeutic practice - in accordance with the patient information leaflet - in a large patient population:

* Retrospective survey of rhinitis/rhinoconjunctivitis symptoms induced by tree pollen
* Overall symptomatology
* Documentation of restrictions caused by allergy/asthma
* Tolerability of the treatment by means of AE documentation
* Patient compliance

Additional requirements extending beyond the specifications listed in the patient information leaflet on product use, patient groups, dosage, contraindications, etc., will not be made.

Eligibility criteria: Inclusion Criteria:

* Patients aged 5 years or older having allergies within the scope of specifications stated in the patient information leaflet

Exclusion Criteria:

* Contraindications according to the patient information leaflet

Primary outcomes:
measure: Assessment of the tolerability of SLIT with LAIS® 2-tree allergoid tablets on the description of adverse events and serious adverse events.
timeFrame: 7 months
measure: Assessment of the tolerability of SLIT with LAIS® 2-tree allergoid tablets on the judgement of the treatment by the investigator and the patient.
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: UHCologne
state: North Rhine-Westphalia
Study officials:
affiliation: University Hospital of Cologne
name: Ralph Mösges, Professor
role: PRINCIPAL_INVESTIGATOR
References: