Tolerability of SLIT With LAIS® 2-Tree Allergoid Tablets

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.

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Key information

Conditions

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

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UHCologne

Cologne, North Rhine-Westphalia, 50931, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

Assessment of the tolerability of SLIT with LAIS® 2-tree allergoid tablets on the description of adverse events and serious adverse events.

Time frame: 7 months

The description of adverse events/serious adverse events (AE/SAE) encompasses frequency, intensity, duration, relationship to LAIS® 2-tree tablets and actions taken due to the treatment with LAIS® 2-tree tablets and other concomitant medication. The documentation of adverse events takes place at visit 1 (before the tree pollen season), at visit 2 (at the peak tree pollen season) and at visit 3 (after the tree pollen season).
Assessment of the tolerability of SLIT with LAIS® 2-tree allergoid tablets on the judgement of the treatment by the investigator and the patient.

Time frame: 7 months

The tolerability of the treatment was judged by the investigator and the patient at visit 2 using a 4-point scale: very well - good - moderate - bad.

Sponsors and collaborators

Lead sponsor

University Hospital of Cologne

Other

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Sep 17, 2015
Registry last updated: Nov 11, 2015

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.

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

Completed