Tolerability of SLIT With LAIS® 2-Tree Allergoid Tablets

NCT02553590 | Completed

• 1 other identifier: LF 2B/Titra/2014/D
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis

Keywords

Non Interventional Study; NIS; sublingual immunotherapy; allergen; tree; birch; alder

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients aged 5 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

Study Sites (1)

UHCologne

Cologne, North Rhine-Westphalia, 50931, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Officials

• Ralph Mösges, Professor

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 17, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 11, 2015

Record last verified: 2015-11

Locations

DE (1)