Tolerability of SLIT With LAIS® Mites Allergoid Tablets
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|ClinicalTrials.gov Identifier: NCT02609581|
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : October 25, 2017
|Condition or disease||Intervention/treatment|
|Allergic Rhinitis||Drug: Sublingual Immunotherapy with tablets (mites)|
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.
|Study Type :||Observational|
|Actual Enrollment :||192 participants|
|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|
|Actual Study Start Date :||December 1, 2015|
|Actual Primary Completion Date :||February 28, 2017|
|Actual Study Completion Date :||February 28, 2017|
- Drug: Sublingual Immunotherapy with tablets (mites)
Sublingual immunotherapy involves putting a tablet of allergen extracts (mites) under the tongue to swallow the extract.Other Name: Sublingual immunotherapy
- Assessment of the tolerability of SLIT with LAIS® mites allergoid tablets on the description of adverse events and serious adverse events. [ Time Frame: 13 month ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609581
|Principal Investigator:||Ralph Mösges, Prof. Dr.||University hospital cologne|