An application documentation to study the clinical effects and the tolerability of the immunoBON FSMP in patients with allergic rhinoconcunctivitis

Phase 4

• Conditions: Allergic rhinoconjunctivitis with/without asthma in cat dander/dust mite/pollen allergic patients.

• Registration Number: DRKS00032757
• Lead Sponsor: Bencard Allergy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-07-14
• Study Start: 2023-09-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

IgE-mediated allergic rhinoconjunctivitis with or without asthma against birch pollen OR house dust mites (HSM) and/or animal epithelia for at least one year (all degrees of severity), confirmed by prick test or by means of corresponding IgE detection in serum (co-sensitizations without clinical relevance are allowed).
- At the time of inclusion, no indication for allergen-specific immunotherapy (AIT) given or AIT not desired by the patient.
- Age from 3 years under the condition that the tablets can be reliably sucked
- Written consent for data collection

Exclusion Criteria

- Intolerance of milk protein
- Diseases of the gastrointestinal tract (e.g. eosinophilic esophagitis) and/or serious diseases which, in the opinion of the investigator, constitute a contraindication to the use of immunoBON
- Medical conditions associated with an increased risk of aspiration
- Ongoing performance of AIT
- Completed AIT for the dominant allergen to be documented within the last 12 months.
- Lactose intolerance to an extent which, in the opinion of the attending physician, constitutes a contraindication to the use of immunoBO

Study & Design

• Study Type: interventional
• Study Design: Not specified