Dust Mite AllergyNCT04872868
Long-term Effect of a 3-month Supplementation With Holo-BLG on House Dust Mite Induced Allergic Rhinoconjunctivitis
An observational study of Dust Mite Allergy and Allergic Rhinitis, run by Ecarf Institute GmbH at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dust Mite Allergy, Allergic Rhinitis
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jan 2021to 12 Feb 2021
- Phase
- Observational
- 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
Study population: study participants must have been participated in the in the predecessor study (supplementation phase with holo-BLG) including complete intake of the holo-BLG lozenge for 3 months and must have been included in the final analysis set of the predecessor study
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Dust Mite Allergy, Allergic Rhinitis
- Medical subject headings
- Dust Mite Allergy, Rhinitis, Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 120 minutes of allergen challenge
Secondary outcomes (10)
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.
Measured: Up to 120 minutes following allergen challenge
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.
Measured: Up to 120 minutes following allergen challenge
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.
Measured: Up to 120 minutes following allergen challenge
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".
Measured: Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes
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
PEF
PEF (peak expiratory flow) liter/minute.
Measured: Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
FEV1
Forced expiratory volume in 1 second, before and after the exposure.
Measured: Recorded at time zero (0) and 120 minutes
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
rescue medication and/or emergency treatment
Need for rescue medication and/or emergency treatment
Measured: during and up to 24 hours after AEC exposure
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start27 Jan 2021
- Primary completion12 Feb 2021
- Study completion12 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dust Mite AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ecarf Institute GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Bencard Allergie GmbH
- Responsible party
- Sponsor
- Investigators
- Sylvia Becker, Study director, Ecarf Institute GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872868
- Sponsor's protocol ID
- 014-P-21
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04872868
- Acronym / sponsor ID
- 014-P-21
- Conditions
- Dust Mite Allergy, Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ecarf Institute GmbHUniversity, hospital or other
- Collaborators
- Bencard Allergie GmbH
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 12 Feb 2021 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- study participants must have been participated in the in the predecessor study (supplementation phase with holo-BLG) including complete intake of the holo-BLG lozenge for 3 months and must have been included in the final analysis set of the predecessor study
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
TSS
Time frame: Up to 120 minutes following allergen challenge
TESS
Time frame: Up to 120 minutes following allergen challenge
TBSS
Time frame: Up to 120 minutes following allergen challenge
VAS
Time frame: Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes
PNIF
Time frame: Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
PEF
Time frame: Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
FEV1
Time frame: Recorded at time zero (0) and 120 minutes
FEV1/FVC
Time frame: Recorded at time zero (0) and 120 minutes
rescue medication and/or emergency treatment
Time frame: during and up to 24 hours after AEC exposure
Adverse events with regards to the allergen exposure
Time frame: up to 24 hours after AEC exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Results publicationBergmann, 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia Becker study director
Ecarf Institute GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dust Mite Allergy and Allergic Rhinitis, run by Ecarf Institute GmbH 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 3 inclusion and 12 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 22 Apr 2022. 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?
TNSS (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 NCT04872868, 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 22 Apr 2022.