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

ALK-Abelló

Status and phase

Completed

Phase 2

Conditions

Conjunctivitis

Asthma

Rhinitis

Treatments

Biological: subcutaneous immunotherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00857779

AF-H-01

Details and patient eligibility

About

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

Enrollment

473 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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
Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ