Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

Last updated: July 13, 2011
Sponsor: Roxall Medizin
Overall Status: Completed

Phase

3

Condition

Acute Rhinitis

Allergy

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT01012531
CLU-2008-001
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or ryepollen

  • Positive screening skin prick test (wheal diameter > 3 mm)

  • Compliance and ability of the patient to complete a Diary Card for self-evaluating ofthe symptoms and antisymptomatic medication

  • Signed and dated patient´s Informed Consent,

Exclusion

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 theinvestigator´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 contraceptiveprotection,

  • Patients being in any relationship or dependency with the sponsor and/or investigator,

  • Treatment with beta-blockers (incl. local application) and/or other contra-indicateddrugs.

Study Design

Total Participants: 121
Study Start date:
October 01, 2008
Estimated Completion Date:
December 31, 2009

Connect with a study center

  • Zentrum für Rhinologie und Allergologie

    Wiesbaden,
    Germany

    Site Not Available

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