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Allergy to CatsNCT05455749

Effect of holoBLG on Cat Allergic Patients

A study testing holoBLG in people with Allergy to Cats and Allergic Rhinoconjunctivitis, run by Allergy Therapeutics at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Allergy to Cats, Allergic Rhinoconjunctivitis
What is being tested?
holoBLG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteGermany
Study dates
4 Oct 2021to 16 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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 locations and contacts

1 site in 1 country.

Germany1 site

  • ECARF Institute GmbH

    Berlin, 10115

Other trials in Germany

About this study

Official 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

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).

Being tested
holoBLG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • holoBLGDietary 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)

Study groups in NCT05455749
Study groupRoleWhat they receive
holoBLGExperimentalNot described
Receives: Dietary Supplement: holoBLG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TSS

    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.

    Measured: After 120 minutes of allergen challenge

Secondary outcomes (11)

  1. TNSS

    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.

    Measured: Up to 120 minutes following allergen challenge

  2. TESS

    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.

    Measured: Up to 120 minutes following allergen challenge

  3. TBSS

    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.

    Measured: Up to 120 minutes following allergen challenge

  4. VAS

    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".

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

  5. PNIF

    PNIF (peak nasal inspiration flow) liter/minute.

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

  6. PEF

    PEF (peak expiratory flow) liter/minute

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

  7. FEV1

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

    Measured: Recorded at time zero (0) and 120 minutes

  8. FEV1/FVC

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

    Measured: Recorded at time zero (0) and 120 minutes

  9. Adverse events with regards to the allergen exposure

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

    Measured: up to 24 hours after AEC exposure

  10. NPT

    Changes in Nasal Provocation Test before and after intervention period

    Measured: up to 3 months following first AEC

  11. TOSS

    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.

    Measured: Up to 120 minutes following allergen challenge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start4 Oct 2021
  3. Primary completion15 Mar 2022
  4. Study completion16 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05455749
Sponsor's protocol ID
039-P-21
Status last verified
Jul 2022
First submitted
8 Jul 2022
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bergmann KC, Raab J, Graessel A, Zwingers T, Becker S, Kugler S, Zuberbier T, Roth-Walter F, Kramer MF, Jensen-Jarolim E. The holo beta-lactoglobulin lozenge reduces symptoms in cat allergy-Evaluation in an allergen exposure chamber and by titrated nasal allergen challenge. Clin Transl Allergy. 2023 Jul;13(7):e12274. doi: 10.1002/clt2.12274.

    PubMed 37488734

Questions about this trial

What is this clinical trial studying?

A study testing holoBLG in people with Allergy to Cats and Allergic Rhinoconjunctivitis, run by Allergy Therapeutics at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TSS (time frame: After 120 minutes of allergen challenge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05455749, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.

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