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EVALUATION OF THE EFFICACY AND SAFETY OF SUBCUTANEOUS IMMUNOTHERAPY (BELTAVAC®) WITH POLYMERIZED ALLERGENIC EXTRACT OF HOUSE DUST MITE MIXTURE IN PATIENTS WITH ALLERGIC RHINITIS/RHINOCONJUNCTIVITIS

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516893-31-01
Acronym
PRO-RCT-ACAROS-2018
Enrollment
250
Registered
2024-10-18
Start date
2022-01-31
Completion date
Unknown
Last updated
2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinoconjunctivitis due to exposure of house dust mites

Brief summary

Score on the combined scale of nasal symptoms and specific medication (CSMS4) of allergy completed by the patient daily in his/her online patient card in periods of 4 weeks repeatedly during the year of follow-up.

Detailed description

- Nasal symptom scale score (SS4). - Specific medication scale score (MS). - Nasal and ocular symptom scale score (SS6) - Combined nasal, ocular symptom and medication scale score (CSMS6). - Percentage of days without symptoms or medication.

Interventions

DRUGBeltavac Polymerized placebo. It is a saline solution without the allergenic extract
DRUGBELTAVAC with polymerized extract From Dermatophagoides

Sponsors

Probelte Pharma S.L.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Secondary

MeasureTime frame
- Nasal symptom scale score (SS4). - Specific medication scale score (MS). - Nasal and ocular symptom scale score (SS6) - Combined nasal, ocular symptom and medication scale score (CSMS6). - Percentage of days without symptoms or medication.

Primary

MeasureTime frame
Score on the combined scale of nasal symptoms and specific medication (CSMS4) of allergy completed by the patient daily in his/her online patient card in periods of 4 weeks repeatedly during the year of follow-up.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026