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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
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Ralph Mösges, University Hospital of Cologne

Brief 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.

Condition or disease Intervention/treatment
Allergic Rhinitis Drug: Sublingual Immunotherapy with tablets (mites)

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® 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.


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Study Type : Observational
Actual Enrollment : 192 participants
Observational Model: Other
Time Perspective: Prospective
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

Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients aged 18 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 (mites).
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
University Hospital of Cologne
Investigators
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Principal Investigator: Ralph Mösges, Prof. Dr. University hospital cologne

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Responsible Party: Prof. Dr. Ralph Mösges, University Hospital of Cologne
ClinicalTrials.gov Identifier: NCT02609581     History of Changes
Other Study ID Numbers: LF HDM/Titra/2015/D
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prof. Dr. Ralph Mösges, University Hospital of Cologne:
Non Interventional Study
NIS
sublingual immunotherapy
allergen
Mites

Additional relevant MeSH terms:
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Immunologic Factors
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Physiological Effects of Drugs