Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients

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

PHASE2

Total Enrollment

473 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-10-31

Brief Summary

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The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ

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Detailed Description

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Conditions

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Rhinitis Conjunctivitis Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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subcutaneous immunotherapy

subcutaneous immunotherapy using a slow updosing schedule

Group Type ACTIVE_COMPARATOR

subcutaneous immunotherapy

Intervention Type BIOLOGICAL

7 injections

subcutaneous injections

subcutaneous immunotherapy using a fast updosing schedule

Group Type ACTIVE_COMPARATOR

subcutaneous immunotherapy

Intervention Type BIOLOGICAL

7 injections

Interventions

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subcutaneous immunotherapy

7 injections

Intervention Type BIOLOGICAL

Other Intervention Names

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AVANZ

Eligibility Criteria

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Inclusion Criteria

* A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
* Lack of adequate relief with symptomatic medication during the previous grass pollen season
* Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter \>= 3mm) currently performed or not older than 60 days before screening

Exclusion Criteria

* FEV1 \< 70% of predicted value at screening
* Bronchial asthma corresponding to GINA step 3 or more, even if controlled
* History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months
* Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No