Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

Efficacy and Safety of Subcutaneous Cluster Immunotherapy With Cluster-allergoid CLUSTOID Grasses/Rye (Glutaraldehyde-polymerized Allergen Extract of Mixtures of Grass and Rye Allergens) in Patients With Allergic Rhinoconjunctivitis Sensitized to Grass and With or Without Rye Pollen Sensitization

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01012531

Enrollment

121

Registered

2009-11-13

Start date

2008-10-31

Completion date

2009-12-31

Last updated

2011-07-14

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

Conditions

Allergic Rhinitis

Brief summary

The objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.

Interventions

BIOLOGICALSubcutaneous injections with highly polymerized allergen extract

cluster schedule

BIOLOGICALSubcutaneous injection with placebo

cluster schedule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen * Positive screening skin prick test (wheal diameter \> 3 mm) * Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication * Signed and dated patient´s Informed Consent,

Exclusion criteria

* Previous immunotherapy with grass and/or rye pollen extracts within the last 3 years, * Simultaneous participation in other clinical trials, * Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), * Auto-immune disorders, * Severe chronic inflammatory diseases, * Malignancy, * Alcohol abuse, * Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, * Patients being in any relationship or dependency with the sponsor and/or investigator, * Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

Design outcomes

Primary

Measure	Time frame
Symptom and medication score	1 year

Secondary

Measure	Time frame
Safety of the treatment during the study period	1 year
Documentation of adverse events	1 year
Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season	1 year
Global evaluation and Quality of life questionnaire	1 year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026