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Effect of holoBLG on Cat Allergic Patients

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Allergy Therapeutics

Status

Completed

Conditions

Allergic Rhinoconjunctivitis
Allergy to Cats

Treatments

Dietary Supplement: holoBLG

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05455749
039-P-21

Details and patient eligibility

About

The aim of the study is to investigate the antigen-unspecific effect of a 3 months supplementation with a food for special medical purposes (FSMP) in form of a lozenge containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols (holo-BLG) in patients with allergic rhinoconjunctivitis caused by cat (hair/dander) and the associated symptoms (symptom type and severity) during exposure to cat allergen in an Allergen Exposure Chamber (AEC).

Enrollment

42 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • At least 1 year of clinically relevant cat allergy
  • positive SPT (wheal >3mm)
  • Positive NPT
  • Increase in TSS >3 during the 1st exposure in the AEC
  • Verbal and written consent

Exclusion criteria

  • subjects <18 years
  • subjects taking immunosuppressive drugs such as systemic corticosteroids, cyclosporine, etc.
  • subjects who have received or are currently receiving sublingual or subcutaneous immunotherapy (SLIT/SCIT) for cat allergy in the last 2 years prior to V0
  • clinically relevant overreactions to the ingredients of holoBLG, in particular subjects with a milk protein allergy or pronounced lactose intolerance
  • subjects with severe asthma and/or a history of uncontrolled asthmatic attacks in the last three months before the selection process (GINA 4 and 5).
  • subjects with an FEV1 <70% (predicted value) prior to exposure in the AEC
  • Lack of verbal and written informed consent
  • subjects who are not proficient in the German language
  • History of serious chronic medical illness and/or any condition for which the local investigator believes that participation in the study could pose a risk to the individual
  • Pregnancy and lactation
  • Contraindications and/or history of adrenaline intolerance and/or emergency medications
  • Concurrent use of anti-allergic medications and/or inadequate washout period of these anti-allergic medications prior to the selection process and exposure in the exposure chamber
  • TSS ≥ 6 at t0 of first exposure in the AEC
  • Subjects who have a history of ingestion of holoBLG

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

42 participants in 1 patient group

holoBLG
Experimental group
Treatment:
Dietary Supplement: holoBLG

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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