Tolerability of SLIT With LAIS® Mites Allergoid Tablets

NCT02609581 | Completed

• 1 other identifier: LF HDM/Titra/2015/D
• Study Type: observational
• Target: 192
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Rhinitis

Keywords

Non Interventional Study; NIS; sublingual immunotherapy; allergen; Mites

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Sublingual Immunotherapy with tablets (mites) DRUG

Sublingual immunotherapy involves putting a tablet of allergen extracts (mites) under the tongue to swallow the extract.

Also known as: Sublingual immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients aged 18 years or older having allergies within the scope of specifications stated in the patient information leaflet

You may not qualify if:

• Contraindications according to the patient information leaflet

Sponsors & Collaborators

• University Hospital of Cologne: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Sublingual Immunotherapy; Tablets

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Immunologic; Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ralph Mösges, Prof. Dr.

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Ralph Mösges

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: December 1, 2015
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share