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Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

This study has been completed.
Information provided by:
Roxall Medizin Identifier:
First received: November 11, 2009
Last updated: July 13, 2011
Last verified: November 2009
The objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.

Condition Intervention Phase
Allergic Rhinitis Biological: Subcutaneous injections with highly polymerized allergen extract Biological: Subcutaneous injection with placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Roxall Medizin:

Primary Outcome Measures:
  • Symptom and medication score [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Safety of the treatment during the study period [ Time Frame: 1 year ]
  • Documentation of adverse events [ Time Frame: 1 year ]
  • Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season [ Time Frame: 1 year ]
  • Global evaluation and Quality of life questionnaire [ Time Frame: 1 year ]

Enrollment: 121
Study Start Date: October 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: highly polymerized allergen extract Biological: Subcutaneous injections with highly polymerized allergen extract
cluster schedule
Placebo Comparator: Placebo Biological: Subcutaneous injection with placebo
cluster schedule


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01012531

Zentrum für Rhinologie und Allergologie
Wiesbaden, Germany
Sponsors and Collaborators
Roxall Medizin
  More Information

Responsible Party: Jenny Uhlig, Roxall Medizin Identifier: NCT01012531     History of Changes
Other Study ID Numbers: CLU-2008-001
Study First Received: November 11, 2009
Last Updated: July 13, 2011

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on June 23, 2017