Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

Phase 3

Completed

• Conditions: Allergic Rhinitis
• Interventions: Biological: Subcutaneous injections with highly polymerized allergen extract; Biological: Subcutaneous injection with placebo

• Registration Number: NCT01012531
• Lead Sponsor: Roxall Medizin

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Status Verified: 2009-11
• Primary Completion: 2009-11
• Study First Submitted: 2009-11-11
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Study Completion: 2009-12
• Last Update Submitted: 2011-07-13
• Last Update Posted: 2011-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
highly polymerized allergen extract	Subcutaneous injections with highly polymerized allergen extract	-
Placebo	Subcutaneous injection with placebo	-

Primary Outcome Measures

Name	Time	Method
Symptom and medication score	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zentrum für Rhinologie und Allergologie; 🇩🇪 Wiesbaden, Germany