Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

This study has been completed.
Sponsor:
Information provided by:
Roxall Medizin
ClinicalTrials.gov Identifier:
NCT01012531
First received: November 11, 2009
Last updated: July 13, 2011
Last verified: November 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of the treatment during the study period [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Documentation of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Global evaluation and Quality of life questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012531

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

No publications provided

Responsible Party: Jenny Uhlig, Roxall Medizin
ClinicalTrials.gov Identifier: NCT01012531     History of Changes
Other Study ID Numbers: CLU-2008-001
Study First Received: November 11, 2009
Last Updated: July 13, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on November 27, 2014