Tolerability of SLIT With LAIS® Mites Allergoid Tablets

Allergic Rhinitis Clinical Trial

Official title:

Non-Interventional Study (NIS) on the Tolerability of Sublingual Immunotherapy With LAIS® Mites Tablets in Consideration of the Chosen Titration Schedule in Everyday Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609581
• Other study ID #: LF HDM/Titra/2015/D
• Status: Completed
• Phase: N/A
• First received: November 17, 2015
• Last updated: October 24, 2017
• Start date: December 1, 2015
• Est. completion date: February 28, 2017

Study information

• Verified date: October 2017
• Source: University Hospital of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To expand knowledge on the application and tolerability of immunotherapy with LAIS® Mites 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.

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® Mites 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® Mites 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Sublingual Immunotherapy with tablets (mites)
Sublingual immunotherapy involves putting a tablet of allergen extracts (mites) under the tongue to swallow the extract.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Cologne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the tolerability of SLIT with LAIS® mites 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® mites tablets and actions taken due to the treatment with LAIS® mites tablets and other concomitant medication. The documentation of adverse events takes place at visit 1, at visit 2 (after titrationphase) and at visit 3 (after first year of treatment).	13 month