Tolerability of SLIT With LAIS® 2-Tree Allergoid Tablets

NCT ID: NCT02553590

Last Updated: 2015-11-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-10-31

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.

Conditions

Allergic Rhinitis

Study Design

• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Ralph Mösges

Prof. Dr. Ralph Mösges

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ralph Mösges, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Cologne

Locations

UHCologne

Cologne, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

LF 2B/Titra/2014/D

Identifier Type: -

Identifier Source: org_study_id