Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

July 13, 2011 updated by: Roxall Medizin

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Wiesbaden, Germany
        • Zentrum für Rhinologie und Allergologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Subcutaneous injection with placebo
cluster schedule
Active Comparator: highly polymerized allergen extract
Biological: Subcutaneous injections with highly polymerized allergen extract
cluster schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom and medication score
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roxall Medizin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 11, 2009

First Submitted That Met QC Criteria

November 12, 2009

First Posted (Estimate)

November 13, 2009

Study Record Updates

Last Update Posted (Estimate)

July 14, 2011

Last Update Submitted That Met QC Criteria

July 13, 2011

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLU-2008-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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