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Completed

NCT Number: NCT04872868

Long-term Effect of a 3-month Supplementation With Holo-BLG on House Dust Mite Induced Allergic Rhinoconjunctivitis

The aim of the study is to investigate the long-term effect of a lozenge containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols (holo-BLG) in people with allergic rhinoconjunctivitis caused by house dust mites and the associated symptoms (symptom type and severity) during exposure to house dust mites in an Allergen Exposure Chamber (AEC).

In particular, the study aims to evaluate whether the improvements in symptoms of house dust mite-induced rhinoconjunctivitis observed after 3 months of supplementation with holo-BLG can still be detected 7 to 8 months after the last intake.

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Key information

Conditions

Dust Mite Allergy Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

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

  • Participation in the predecessor study including complete intake of the holo-BLG lozenge for 3 months; inclusion in the final analysis set of the predecessor study
  • patients with allergic rhinoconjunctivitis caused by house dust mites of any gender, aged 18-65 years
  • Verbal and written informed consent

Exclusion criteria

  • Persons <18 years
  • lack of verbal and written consent
  • persons who do not speak German
  • seriously ill persons
  • Persons with immunosuppressive medication such as systemic corticosteroids, cyclosporine
  • Pregnancy and breastfeeding
  • psychiatric illness
  • Persons who have received or have started sublingual or subcutaneous immunotherapy (SLIT/SCIT) against house dust mites in the last 2 years before screening
  • Contraindications and/or history of adrenaline intolerance and/or emergency medication.
  • 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
  • Use of an investigational drug 30 days/5 half-lives of the drug (whichever is longer) prior to screening
  • Use of certain drugs prior to V5: Systemic corticosteroids within 3 weeks; Topical nasal corticosteroids within 2 weeks; Chromones within 7 days; Antihistamines within 72h; Antibiotics within 3 months; Pro-, Pre- and Synbiotics 1 month

Treatment and study plan

Primary outcomes

  1. TNSS

    Time frame: After 120 minutes of allergen challenge

    Total Nasal Symptom Score (TNSS) in response to HDM exposure in an AEC at V1 (baseline AEC exposure) versus V5 (follow-up AEC exposure). The 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.

Secondary outcomes

  1. TSS

    Time frame: Up to 120 minutes following allergen challenge

    Total Symptom Score in response to HDM exposure in an AEC at V1 (baseline AEC exposure) versus V5 (follow-up AEC exposure). The TSS is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose), 3 eye symptoms (itchy eyes, watery eyes, and gritty feeling), 4 bronchial symptoms (wheezing, cough, breathlessness, and asthma), 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 39.

  2. TESS

    Time frame: Up to 120 minutes following allergen challenge

    The Total Eye Symptom Score (TESS) is the sum of 3 eye symptoms (itchy eyes, watery eyes, and gritty feeling) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TESS of 9.

  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, and asthma) 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 the 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. rescue medication and/or emergency treatment

    Time frame: during and up to 24 hours after AEC exposure

    Need for rescue medication and/or emergency treatment

  10. 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.

Sponsors and collaborators

Lead sponsor

Ecarf Institute GmbH

Other

Collaborators

  • Bencard Allergie GmbH

Registry information

Official study title

Evaluation of the Long-term Effect of a 3-month Supplementation With Holo-BLG (Food for Special Medical Purposes) in People With Allergic Rhinoconjunctivitis Caused by House Dust Mites During Inhalation Exposure to Mite Allergen in an Exposure Chamber.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 5, 2021
Registry last updated
Apr 22, 2022

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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