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Completed

NCT Number: NCT05455749

Effect of holoBLG on Cat Allergic Patients

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ECARF Institute GmbH

Berlin, 10115, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

holoBLG

Dietary Supplement

holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, loaded with ligands (vitamin A, zinc and polyphenol-iron complexes)

Primary outcomes

  1. TSS

    Time frame: After 120 minutes of allergen challenge

    Total Symptom Score in response to cat exposure in an AEC at baseline versus final AEC exposure. The TSS is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose), 4 eye symptoms (itchy eyes, watery eyes, gritty feeling, eye reddening), 4 bronchial symptoms (wheezing, cough, breathlessness, rhonchus), and 2 other symptoms (itchy palate, and itchy skin) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TSS of 42.

Secondary outcomes

  1. TNSS

    Time frame: Up to 120 minutes following allergen challenge

    The Total Nasal Symptom Score (TNSS) is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TNSS of 12.

  2. TESS

    Time frame: Up to 120 minutes following allergen challenge

    The Total Eye Symptom Score (TESS) is the sum of 4 eye symptoms (itchy eyes, watery eyes, gritty feeling, eye reddening) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TESS of 12.

  3. TBSS

    Time frame: Up to 120 minutes following allergen challenge

    The Total Bronchial Symptom Score (TBSS) is the sum of 4 bronchial symptoms (wheezing, cough, breathlessness, rhonchus) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TBSS of 12.

  4. VAS

    Time frame: Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes

    Visual Analogue Scale: Before, every 30 minutes during and after each exposure patients grade the question on their well-being by putting a vertical line on a 10 cm line representing severity from 0 cm "very good" to 10 cm "very bad".

  5. PNIF

    Time frame: Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes

    PNIF (peak nasal inspiration flow) liter/minute.

  6. PEF

    Time frame: Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes

    PEF (peak expiratory flow) liter/minute

  7. FEV1

    Time frame: Recorded at time zero (0) and 120 minutes

    Forced expiratory volume in 1 second, before and after the exposure

  8. FEV1/FVC

    Time frame: Recorded at time zero (0) and 120 minutes

    Forced expiratory volume in 1 second/forced vital capacity ratio, before and after the exposure.

  9. Adverse events with regards to the allergen exposure

    Time frame: up to 24 hours after AEC exposure

    Number of events and number of patients recording late-phase reactions and/or adverse events with regards to the allergen exposure

  10. NPT

    Time frame: up to 3 months following first AEC

    Changes in Nasal Provocation Test before and after intervention period

  11. TOSS

    Time frame: Up to 120 minutes following allergen challenge

    The Total Other Symptom Score (TBSS) is the sum of 2 additional symptoms (itchy palate, itchy skin) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TOSS of 6.

Sponsors and collaborators

Lead sponsor

Allergy Therapeutics

Industry

Collaborators

  • Bencard Allergie GmbH
  • Ecarf Institute GmbH

Registry information

Official study title

A Prospective Pilot Study to Observe the Effects of Cat Exposure in an Allergen Exposure Chamber (AEC) in Cat Allergic Patients Taking a Food for Special Medical Purposes (holoBLG) for 3 Months

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2022
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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