Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

NCT ID: NCT01012531

Last Updated: 2011-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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highly polymerized allergen extract

Group Type ACTIVE_COMPARATOR

Subcutaneous injections with highly polymerized allergen extract

Intervention Type BIOLOGICAL

cluster schedule

Placebo

Group Type PLACEBO_COMPARATOR

Subcutaneous injection with placebo

Intervention Type BIOLOGICAL

cluster schedule

Interventions

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Subcutaneous injections with highly polymerized allergen extract

cluster schedule

Intervention Type BIOLOGICAL

Subcutaneous injection with placebo

cluster schedule

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roxall Medizin

INDUSTRY

Sponsor Role lead

Responsible Party

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Roxall Medizin

Locations

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Zentrum für Rhinologie und Allergologie

Wiesbaden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CLU-2008-001

Identifier Type: -

Identifier Source: org_study_id

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