Tolerability of SLIT With LAIS® 2-Tree Allergoid Tablets

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis

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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50931
      • UHCologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the tolerability of SLIT with LAIS® 2-tree allergoid tablets on the description of adverse events and serious adverse events.	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).	7 months
Assessment of the tolerability of SLIT with LAIS® 2-tree allergoid tablets on the judgement of the treatment by the investigator and the patient.	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.	7 months

Collaborators and Investigators

• Sponsor: University Hospital of Cologne
• Investigators: Principal Investigator: Ralph Mösges, Professor, University Hospital of Cologne

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Estimate): November 11, 2015
• Last Update Submitted That Met QC Criteria: November 10, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: NIS; sublingual immunotherapy; birch; allergen; Non Interventional Study; tree; alder
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: LF 2B/Titra/2014/D