Intraseasonal Short-time Up-dosing With Alutard SQ Grasses

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: Allergy

Treatments: Biological: Allergy vaccination (Alutard SQ)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807547

SHX0562

Details and patient eligibility

About

Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing

Enrollment: 149 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• history of grass pollen induced allergic rhinoconjunctivitis
• positive skin prick test

Exclusion criteria

• uncontrolled severe bronchial asthma
• previous treatment with immunotherapy within the previous 5 years
• contraindication for specific immunotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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149 participants in 2 patient groups, including a placebo group

Allergy vaccination

Active Comparator group

Description:

Allergy vaccination by 6 subcutaneous injections to 10,000 SQ-U with 1-3 days intervals, continuation by 2 injections with 10,000 SQ-U with 2-4 weeks intervals

Treatment:

Biological: Allergy vaccination (Alutard SQ)

Subcutaneous injections

Placebo Comparator group

Description:

Placebo injections

Treatment:

Biological: Allergy vaccination (Alutard SQ)