Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012531
• Other study ID #: CLU-2008-001
• Status: Completed
• Phase: Phase 3
• First received: November 11, 2009
• Last updated: July 13, 2011
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: November 2009
• Source: Roxall Medizin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Biological:
• Subcutaneous injections with highly polymerized allergen extract
cluster schedule
• Subcutaneous injection with placebo
cluster schedule

Locations

Country	Name	City	State
Germany	Zentrum für Rhinologie und Allergologie	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Roxall Medizin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom and medication score		1 year	Yes
Secondary	Safety of the treatment during the study period		1 year	Yes
Secondary	Documentation of adverse events		1 year	Yes
Secondary	Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season		1 year	Yes
Secondary	Global evaluation and Quality of life questionnaire		1 year	No