Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

ROXALL

Status and phase

Completed

Phase 3

Conditions

Allergic Rhinitis

Treatments

Biological: Subcutaneous injection with placebo

Biological: Subcutaneous injections with highly polymerized allergen extract

Study type

Interventional

Funder types

Industry

Identifiers

CLU-2008-001

Details and patient eligibility

About

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

Enrollment

121 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.