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Prospective, multicentre, randomized, double-blind, placebo-controlled, clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and cupressaceae

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514524-16-00
Acronym
DMV02-SIT-026
Enrollment
180
Registered
2024-08-14
Start date
2021-05-11
Completion date
Unknown
Last updated
2025-09-05

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

Conditions

Aetiological treatment of moderate-severe intermitent or persistent allergic rhinitis/rhinoconjunctivitis with or without controlled mild-moderate intermittent or persistent allergic asthma

Brief summary

Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS) during the pollen season and pollen peak of cupressaceae (January, February and March) and grasses (May and June).

Detailed description

Symptom free days in rhinitis/rhinoconjunctivitis and asthma, Medication-free days in rhinitis/rhinoconjunctivitis and asthma, Symptom score in rhinitis/rhinoconjunctivitis (RSS) during pollen season and pollen peak of grasses and cupressaceae., Medication score in rhinitis/rhinoconjunctivitis (RMS) during pollen season and pollen peak of grasses and cupressaceae., Combined symptom and medication score (ACSMS) during pollen season and pollen peak of grasses and cupressaceae., Asthma symptom score (ASS) during pollen season and pollen peak of grasses and cupressaceae., Asthma Medication Score (AMS) during pollen season and pollen peak of grasses and cupressaceae., Asthma and rhinitis/rhinoconjunctivitis symptom score (ARSS) during pollen season and pollen peak of grasses and cupressaceae., Asthma and rhinitis/rhinoconjunctivitis medication score (ARMS) during pollen season and pollen peak of grasses and cupressaceae, Combined symptom and medication score in asthma and rhinitis/rhinoconjunctivitis (ARCSMS) during pollen season and pollen peak of grasses and cupressaceae., Asthmatic exacerbations: time to first occurrence of asthmatic exacerbation, number, duration and severity., Visual Analogue Scale (VAS), Immunological parameters (total IgE, specific IgE and specific IgG4)., Asthma Control Questionnaire (ACQ-6)., Rhinitis Follow-up Questionnaire (ESPRINT-15)., Register of consumption of health resources., Safety of specific immunotherapy (Overall rate, severity, and ratio of any adverse event (AE) by administration and by subject; Evaluation of administration site reactions, systemic reactions and any medication administered for the treatment of AE)

Interventions

DRUGMixture of modified allergen extracts of 6 grasses (MG01) and modified allergen extract of Juniperus oxycedrus (T521)

Sponsors

Inmunotek S.L.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS) during the pollen season and pollen peak of cupressaceae (January, February and March) and grasses (May and June).

Secondary

MeasureTime frame
Symptom free days in rhinitis/rhinoconjunctivitis and asthma, Medication-free days in rhinitis/rhinoconjunctivitis and asthma, Symptom score in rhinitis/rhinoconjunctivitis (RSS) during pollen season and pollen peak of grasses and cupressaceae., Medication score in rhinitis/rhinoconjunctivitis (RMS) during pollen season and pollen peak of grasses and cupressaceae., Combined symptom and medication score (ACSMS) during pollen season and pollen peak of grasses and cupressaceae., Asthma symptom score (ASS) during pollen season and pollen peak of grasses and cupressaceae., Asthma Medication Score (AMS) during pollen season and pollen peak of grasses and cupressaceae., Asthma and rhinitis/rhinoconjunctivitis symptom score (ARSS) during pollen season and pollen peak of grasses and cupressaceae., Asthma and rhinitis/rhinoconjunctivitis medication score (ARMS) during pollen season and pollen peak of grasses and cupressaceae, Combined symptom and medication score in asthma and rhinitis/rhinoconj

Countries

Spain

Outcome results

None listed

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