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Completed

NCT Number: NCT01012531

Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

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

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zentrum für Rhinologie und Allergologie

Wiesbaden, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subcutaneous injections with highly polymerized allergen extract

Biological

cluster schedule

Subcutaneous injection with placebo

Biological

cluster schedule

Primary outcomes

  1. Symptom and medication score

    Time frame: 1 year

Secondary outcomes

  1. Safety of the treatment during the study period

    Time frame: 1 year

  2. Documentation of adverse events

    Time frame: 1 year

  3. Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season

    Time frame: 1 year

  4. Global evaluation and Quality of life questionnaire

    Time frame: 1 year

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Roxall Medizin

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 13, 2009
Registry last updated
Jul 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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