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A non-interventional observational study in adults and children from 5 years of age assessing the safety and tolerability of GRAZAX® in case of concomitant specific immunotherapy (SCIT or SLIT)

A non-interventional observational study in adults and children from 5 years of age assessing the safety and tolerability of GRAZAX® in case of concomitant specific immunotherapy (SCIT or SLIT)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00005009
Enrollment
300
Registered
2013-05-22
Start date
2012-01-19
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

grass pollen induced allergic rhinoconjunctivitis J30.1

Interventions

Group 1: routine treatment with grass immunotherapy tablet (grass AIT, GRAZAX) and concomitant further specific immunothereapy, documentation of tolerability

Sponsors

ALK-Abelló Arzneimittel GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to No maximum

Inclusion criteria

Inclusion criteria: The tolerability of the grass immunotherapy tablet (GRAZAX) during routine treatment is recorded in children and adults who are treated concomitantly with additional specific immunotherapy for treatment of further allergies.

Exclusion criteria

Exclusion criteria: Contraindications of specific immunotherapy

Design outcomes

Primary

MeasureTime frame
Frequency and type of adverse events recorded by the physician at first application and in patient diaries during home treatment coded acc. to MedDRA

Secondary

MeasureTime frame
Global assessment of tolerability by physician and patient

Countries

Germany

Contacts

Public ContactHendrik Wolf

ALK-Abelló Arzneimittel GmbH, Clinical Development

hendrik.wolf@alk.net+49 40 703845-342

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026