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

Allergic Rhinitis Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872868
• Other study ID #: 014-P-21
• Status: Completed
• Start date: January 27, 2021
• Est. completion date: February 12, 2021

Study information

• Verified date: April 2021
• Source: Ecarf Institute GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 12, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Dust Mite Allergy
• Rhinitis
• Rhinitis, Allergic

Locations

Country	Name	City	State
Germany	ECARF Institute GmbH	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Ecarf Institute GmbH	Bencard Allergie GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Bergmann, KC., Raab, J., Krause, L. et al. Long-term benefits of targeted micronutrition with the holoBLG lozenge in house dust mite allergic patients. Allergo J Int (2022). https://doi.org/10.1007/s40629-021-00197-z

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TNSS	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.	After 120 minutes of allergen challenge
Secondary	TSS	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.	Up to 120 minutes following allergen challenge
Secondary	TESS	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.	Up to 120 minutes following allergen challenge
Secondary	TBSS	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.	Up to 120 minutes following allergen challenge
Secondary	VAS	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".	Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes
Secondary	PNIF	PNIF (peak nasal inspiration flow) liter/minute.	Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
Secondary	PEF	PEF (peak expiratory flow) liter/minute.	Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
Secondary	FEV1	Forced expiratory volume in 1 second, before and after the exposure.	Recorded at time zero (0) and 120 minutes
Secondary	FEV1/FVC	Forced expiratory volume in 1 second/forced vital capacity ratio, before and after the exposure.	Recorded at time zero (0) and 120 minutes
Secondary	rescue medication and/or emergency treatment	Need for rescue medication and/or emergency treatment	during and up to 24 hours after AEC exposure
Secondary	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.	up to 24 hours after AEC exposure