A randomised, parallel-group, open, controlled Phase III trial assessing the treatment compliance with GRAZAX in subjects with seasonal grass pollen induced rhinoconjunctivitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004724-39-DE

Enrollment

500

Registered

2005-12-12

Start date

2006-02-13

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

IgE mediated allergy (hay fever, rhinoconjunctivitis) to grass pollen (Timothy grass, Phleum pratense) with or without asthma MedDRA version: 8.1 Level: PT Classification code 10039085

Interventions

Product Name: Grazax Product Code: ALK Grass tablet Pharmaceutical Form: Oral lyophilisate Other descriptive name: Phleum pratense grass pollen allergen Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female 18-65 years of age A clinical history of grass pollen induced allergic rhinoconjunctivitis requiring treatment during the grass pollen season. Positive Skin Prick Test (SPT) response (wheal diameter >3mm) to Phleum pratense. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: At randomisation, current symptoms of or treatment for upper respiratory tract infection, acute sinuitis, acute otitis media or other relevant infectious process. History of Anaphylaxis or angioedema.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate if subject compliance of once daily dosing with GRAZAX in adult subjects with grass pollen induced allergic rhinoconjunctivitis can be increased by providing subjects with the compliance device based on drug accountability.;Secondary Objective: To evaluate the safety of specific immunotherapy GRAZAX in subjects with grass pollen induced rhinoconjunctivitis with or without asthma.;Primary end point(s): The primary endpoint is "excellent" versus "less excellent" compliance. "Excellent" compliance is defined as subjects with a compliance of 90% or more while "less excellent" compliance is less than 90% from Visit 1 to Visit 3.	—

Measure

Time frame

Main Objective: To evaluate if subject compliance of once daily dosing with GRAZAX in adult subjects with grass pollen induced allergic rhinoconjunctivitis can be increased by providing subjects with the compliance device based on drug accountability.;Secondary Objective: To evaluate the safety of specific immunotherapy GRAZAX in subjects with grass pollen induced rhinoconjunctivitis with or without asthma.;Primary end point(s): The primary endpoint is "excellent" versus "less excellent" compliance. "Excellent" compliance is defined as subjects with a compliance of 90% or more while "less excellent" compliance is less than 90% from Visit 1 to Visit 3.

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Countries

Denmark, Germany, Sweden

Outcome results

None listed

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